Trial of the PresVIEW Implant for the Improvement of Near Vision in Patients With Presbyopia

• Sponsor: Refocus Group, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01166568
• Collaborator: (none)
• Enrollment: 337
• Locations: 14
• Arms: 3
• Duration (Months): 135
• Patients Per Site: 24.1
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

The primary objective of this study is to evaluate the safety and effectiveness of the PresVIEW™ Scleral Implant (PSI) for the improvement of near visual acuity in presbyopic patients.

Condition or Disease	Intervention/Treatment	Phase
Presbyopia	Device: PresVIEW Scleral Implants	N/A

Detailed Description

The clinical investigation of the PresView™ Scleral Implant (PSI) is a prospective multicenter clinical trial in which a total of 330 subjects were enrolled and implanted with the PSI and followed for a period of 24 months at up to 14 clinical sites.

An additional randomized sub-study was performed on 48 subjects with the PSI Second Generation PresView™(SGP) implant, model number SGP-046. A 2:1 randomization was used to determine the 32 subjects assigned to be implanted and the 16 subjects assigned to the observation/deferred implantation control arm. Subjects randomized to the deferred implantation control arm were eligible to receive the PSI after completion of the 6 months of observation in the study.

All subjects interested in participating in the study were screened for eligibility, and informed consent was obtained from those who meet the inclusion/exclusion criteria. Eligible subjects were examined preoperatively to obtain a medical history and baseline ocular data.

Effectiveness: The following tests/measurements used to evaluate the effectiveness of the PSI procedure will be included in the study protocol:

• Near visual acuity of the operated eye/eyes as compared with baseline (uncorrected and distance corrected)

• Reading acuity of the operated eye/eyes as compared with baseline (uncorrected and distance corrected)

The PSI procedure will be defined as successful if a logMar equivalent to Snellen 20/40 or better (logMar 0.3) is achieved in ≥ 75% of patients or if 75% of patients realize an improvement ≥ 2 lines in distance corrected near visual acuity (DCNVA). For most patients, this will translate into the ability to read the majority of newspaper and magazine print without a near optical aid.

Safety: Primary safety outcomes for safety will include:

• Incidence of anterior segment ischemia

• Decrease in Best Corrected Distance Visual Acuity (BCDVA) of more than 2 lines from baseline at 1-month or more postoperatively

• Decrease in best distance corrected near acuity (with add) of more than 2 lines from baseline at 1-month or more postoperatively

• Intraocular Pressure (IOP) increase > 10mm Hg over baseline or IOP > 25mm Hg after 1 Day postoperative

• Signs of chronic inflammation (e.g. uveitis or chronic conjunctival hyperemia) at 2 months or more postoperatively

• Increase in axial length of ≥ 0.20mm accompanied by a > 0.5 diopter myopic shift in manifest spherical equivalent distance refraction.

• Incidence of adverse events: total not to exceed 5%, and the incidence of each event should not exceed 1-2%

Study Design

• Study Type: Interventional
• Actual Enrollment: 337 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: A non-randomized arm was run in parallel with a randomized sub-study consisting of 2 arms; Immediate Treatment and Deferred Treatment. Upon completion of the 6 month observation period, the Deferred Treatment group then crosses over upon implantation to become part of the overall study group.A non-randomized arm was run in parallel with a randomized sub-study consisting of 2 arms; Immediate Treatment and Deferred Treatment. Upon completion of the 6 month observation period, the Deferred Treatment group then crosses over upon implantation to become part of the overall study group.
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Prospective, Multicenter Clinical Trial Of the PresVIEW Scleral Implant (PSI) For the Improvement Of Near Visual Acuity In Presbyopic Patients
• Study Start Date: Dec 1, 2003
• Actual Primary Completion Date: Mar 1, 2015
• Actual Study Completion Date: Mar 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Implantation-Non Randomized Subjects are not participants in the randomized sub-study. PresView Scleral Implants surgical placed in the eye(s) after enrollment and meeting inclusion/exclusion criteria.	Device: PresVIEW Scleral Implants; Subjects are implanted with the PresView Scleral Spacing Implants and followed for 24 months.
Experimental: Implantation-Randomized Subjects are participants in the randomized sub-study. Subjects were randomized to the Immediate Treatment group. PresView Scleral Implants surgical placed in the eye(s)Subjects are participants in the randomized sub-study after enrollment and meeting inclusion/exclusion criteria.	Device: PresVIEW Scleral Implants; Subjects are implanted with the PresView Scleral Spacing Implants and followed for 24 months.
No Intervention: Deferred Implantation-Randomized Subjects are participants in the randomized sub-study after enrollment and meeting inclusion/exclusion criteria. Subjects were randomized to the Deferred Treatment group are observed for 6 months. Upon completion of the observation follow-up, subjects can opt to have PresView Scleral Implants surgically placed in the eye(s) and become part of the overall study experimental group.

Outcome Measures

Primary Outcome Measures

1. Number of Primary Eyes With Distance Corrected Near Visual Acuity (DCNVA) to 20/40 or Better or Improvement of 2 or More Lines [From date of baseline measurement until the date of study withdrawal or study completion, whichever came first, assessed up to 2 years.]

   Measurement of the Distance Corrected Near Visual Acuity at 40 centimeters achieving 20/40 or better or improvement of 2 or more lines at 24 months for the primary eye.

Secondary Outcome Measures

1. Presence of Significant Safety Events (SAEs). [From initiation of the implantation procedure (operative day) until study completion at 24 months or withdrawal from the study.]

   The point estimate were calculated for clinically significant adverse events (SAE's) at the end of the study. Incidence of adverse event totals should not to exceed 5%, and the incidence of each event should not exceed 1-2%. NOTE: Because the secondary outcome is a safety measure, both primary and fellow eyes were used for analysis.

Other Outcome Measures

1. Safety Parameter Point Estimate -- Anterior Segment Ischemia [From initiation of the implantation procedure (operative day) until study completion at 24 months or withdrawal from the study.]

   All primary and fellow eyes implanted with the PSI were included in the safety analysis. Point estimates were calculated for the incidence of Anterior Segment Ischemia at the end of the study. Incidence of adverse event totals should not to exceed 5%, and the incidence of each event should not exceed 1-2% NOTE: Because the secondary outcome is a safety measure, both primary and fellow eyes were used for analysis.

2. Safety Parameter Point Estimate -- Decrease in BCDVA > 2 Lines [From initiation of the implantation procedure (operative day) until study completion at 24 months or withdrawal from the study.]

   All primary and fellow eyes implanted with the PSI were included in the safety analysis. Point estimates were calculated for the incidence of Decrease in BCDVA > 2 lines at the end of the study. Incidence of adverse event totals should not to exceed 5%, and the incidence of each event should not exceed 1-2%. NOTE: Because the secondary outcome is a safety measure, both primary and fellow eyes were used for analysis.

3. Safety Parameter Point Estimate -- Decrease in BCNVA > 2 Lines [From initiation of the implantation procedure (operative day) until study completion at 24 months or withdrawal from the study.]

   All primary and fellow eyes implanted with the PSI were included in the safety analysis. Point estimates were calculated for the incidence of Decrease in BCNVA > 2 lines at the end of the study. Incidence of adverse event totals should not to exceed 5%, and the incidence of each event should not exceed 1-2%. NOTE: Because the secondary outcome is a safety measure, both primary and fellow eyes were used for analysis.

4. Safety Parameter Point Estimate -- (IOP Increase > 10 mmHg) or (IOP > 25 mmHg) [From initiation of the implantation procedure (operative day) until study completion at 24 months or withdrawal from the study.]

   All primary and fellow eyes implanted with the PSI were included in the safety analysis (i.e. both primary and fellow eyes). Point estimates were calculated for the incidence of (IOP Increase > 10 mmHg) or (IOP > 25 mmHg) at the end of the study. Incidence of adverse event totals should not to exceed 5%, and the incidence of each event should not exceed 1-2%. NOTE: Because the secondary outcome is a safety measure, both primary and fellow eyes were used for analysis.

5. Safety Parameter Point Estimate -- Chronic Inflammation [From initiation of the implantation procedure (operative day) until study completion at 24 months or withdrawal from the study.]

   All primary and fellow eyes implanted with the PSI were included in the safety analysis. Point estimates were calculated for the incidence of Chronic Inflammation at the end of the study. Incidence of adverse event totals should not to exceed 5%, and the incidence of each event should not exceed 1-2%. NOTE: Because the secondary outcome is a safety measure, both primary and fellow eyes were used for analysis.

6. Safety Parameter Point Estimate -- (Axial Length Increase >= 0.20) AND (Myopic Shift > 0.50D MRSE) [From initiation of the implantation procedure (operative day) until study completion at 24 months or withdrawal from the study.]

   All primary and fellow eyes implanted with the PSI were included in the safety analysis. Point estimates were calculated for the incidence of (Axial Length Increase >= 0.20) AND (Myopic Shift > 0.50D MRSE) at the end of the study. Incidence of adverse event totals should not to exceed 5%, and the incidence of each event should not exceed 1-2%. NOTE: Because the secondary outcome is a safety measure, both primary and fellow eyes were used for analysis.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Subject must be between 50-60 years old

• Subject must have a best corrected distance visual acuity of 20/20 or better

• Subject must have SLOAN distance corrected near visual acuity @ 40cm in the operative eye/eyes of 20/50 to 20/100 (inclusive).

• Subject should have a manifest distance spherical equivalent refractive correction in the operative eye/eyes of from -0.50 to +0.75 diopters with no more than 1.00 diopter of astigmatism and should require at least a +1.50 diopter add. The distance manifest refraction spherical equivalent and the distance cycloplegic refraction spherical equivalent must be within 0.50 diopters of each other.

• Subject must be phakic in the study eye

• Subject must be mentally competent to understand and comply with the requirements of the study.

• Subject must be able to provide written informed consent.

Exclusion Criteria:

• Chronic uveitis or other recurrent anterior or posterior segment inflammation in either eye.

• Scleral thickness less than 530 μm in the operative eye/eyes.

• Any previous eye surgeries including cataract, LASIK, or Muscle surgery

• Any history of prior extraocular muscle surgery, specifically the recti or oblique muscles.

• Any chronic systemic diseases such as diabetes, heart disease, Lupus, etc.

• Any eye diseases such as eye inflammation, infection, cataract, or retinal diseases

• Allergic to any medications used in the study.

• The patient may not have participated in a device clinical study for the operative eye within the last 3 months and may not have been implanted with PSI devices in this or any other study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Boxer-Wachler Vision Institute	Beverly Hills	California	United States	90210
2	Gordon-Weiss-Schanzlin Vision Institute	San Diego	California	United States	92122
3	The Midwest Center for Sight	Des Plaines	Illinois	United States	60016
4	Jacksoneye	Lake Villa	Illinois	United States	60046
5	Vision/Advanced Eye Center	Lombard	Illinois	United States	60148
6	The Eye Care Institute	Louisville	Kentucky	United States	40206
7	Associated Vision Consultants	Southfield	Michigan	United States	48034
8	Cornea Associates	Omaha	Nebraska	United States	68144
9	Fichte, Endl and Elmer Eyecare Creekside Center	Amherst	New York	United States	14228
10	Southeastern Eye Center	Greensboro	North Carolina	United States	27410
11	Eye Associates of South Tulsa	Tulsa	Oklahoma	United States	74133
12	Wang Vision Institute	Nashville	Tennessee	United States	37203
13	Braverman-Terry-Oei-Eye Associates	San Antonio	Texas	United States	78212
14	The Center for Corrective Eye Surgery	San Antonio	Texas	United States	78215

Sponsors and Collaborators

• Refocus Group, Inc.

Investigators

• Principal Investigator: David Schanzlin, M.D., Chief Medical Officer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• US Food and Drug Administration Website

Publications

None provided.

• Responsible Party: Refocus Group, Inc.
• ClinicalTrials.gov Identifier: NCT01166568
• Other Study ID Numbers: P-277-5
• First Posted: Jul 21, 2010
• Last Update Posted: Sep 28, 2018
• Last Verified: Aug 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Refocus Group, Inc.: Presbyopia; Reading Vision; Near Vision
• Additional relevant MeSH terms: Presbyopia

Study Results

Participant Flow

Recruitment Details	The prospective, multicenter clinical trial of the PresView Implant was conducted at 14 clinical sites. All recruitment evaluations were performed at the Principal Investigator's sites and subjects were screened for eligibility. If inclusion/exclusion criteria were met, informed consent was obtained and the subject was enrolled in the study.
Pre-assignment Detail	Once determined eligible and informed consent was obtained, both eyes were enrolled in the study. Per protocol, primary outcome analysis must be performed on the primary eye only and the primary eye is therefore the unit of analysis. Fellow eyes were followed for safety outcomes and summarized separately.

Arm/Group Title	PresVIEW Implantation - Non-Randomized	PresVIEW Implantation - Randomized	PresVIEW Deferred Implantation - Randomized
Arm/Group Description	Subjects in the non-randomized arm of the study were bilaterally implanted and followed for 24 months. Per the protocol, primary endpoint analysis was performed on the primary eye (only). Fellow eyes were followed for safety and summarized separately	A randomized sub-study was used to evaluate the early (6 Month) effectiveness of the PresVIEW™ Scleral Implants against a deferred control group (no treatment). Subjects in the randomized sub-study that were randomly assigned to the immediate treatment (surgical) group were bilaterally implanted and followed for 24 months. Pre-operative, 3 month and 6 month post-operative visual acuity for the primary eye was compared to the differed treatment group primary eye visual acuity results. Thirty-two subjects of the total 48 subjects participating in the randomized sub-study, were randomly assigned to receive immediate surgery.	Subjects in the randomized sub-study that were randomly assigned to the deferred treatment (control) group were bilaterally implanted after 6 months observation and followed for 24 months post-op. Sixteen subjects of the total 48 subjects participating in the randomized sub-study were randomly assigned to the control group and followed for 6 months prior to surgery (observation). These patients will provide additional informed consent for implantation and their results will be included in the total patient cohort for the PSI SGP-046. Total study participation will be either 6 months (if they did not elect treatment after 6 months observation), or 30 months (6 months observation + 24 months post-operative) if they elected treatment. The observation period included follow-up visits for Day 0 (baseline), 3 months, and 6 months for the randomized sub-study and visual acuity for the primary eye was compared to the immediate treatment group primary eye visual acuity for analysis.
Period Title: Deferred Implantation- Randomized
STARTED	0	0	16
COMPLETED	0	0	15
NOT COMPLETED	0	0	1
Period Title: Deferred Implantation- Randomized
STARTED	288	33	9
COMPLETED	274	32	8
NOT COMPLETED	14	1	1

Baseline Characteristics

Arm/Group Title	PresVIEW Implantation Non-Randomized	PresVIEW Implantation - Randomized	PresVIEW Deferred Implantation - Randomized	Total
Arm/Group Description	288 subjects that received the PresView Scleral Implants, which were surgical placed in the sclera of the eye. Subjects were followed for 24 months. This sample consists of; 16 randomized deferred implantation subjects, 32 randomized implantation subjects, and 282 non-randomized implanted subjects (i.e. all enrolled subjects).	33 randomized subjects entered into a immediate treatment (implantation) group. Subjects were followed for 24 months. Immediate treatment group data was compared to the Deferred Treatment group at 6 months.	16 randomized subjects entered into a deferred treatment (control) group arm. Subjects were followed for 6 months (observation). Subjects that completed the 6 month observation were then offered PresVIEW implantation.	Total of all reporting groups
Overall Participants	288	33	16	337
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	54.92 (2.90)	54.62 (2.96)	55.03 (2.66)	54.93 (2.88)
Sex: Female, Male (Count of Participants)
Female	128 44.4%	15 45.5%	8 50%	151 44.8%
Male	160 55.6%	18 54.5%	8 50%	186 55.2%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	32 11.1%	6 18.2%	2 12.5%	40 11.9%
Not Hispanic or Latino	256 88.9%	27 81.8%	14 87.5%	297 88.1%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	4 1.4%	0 0%	0 0%	4 1.2%
Asian	2 0.7%	0 0%	0 0%	2 0.6%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%
Black or African American	12 4.2%	0 0%	0 0%	12 3.6%
White	258 89.6%	27 81.8%	14 87.5%	299 88.7%
More than one race	0 0%	0 0%	0 0%	0 0%
Unknown or Not Reported	12 4.2%	6 18.2%	2 12.5%	20 5.9%
Region of Enrollment (Count of Participants)
United States	288 100%	33 100%	16 100%	337 100%
DCNVA 20/40 or Better (at baseline) (Count of Participants)
Count of Participants [Participants]	1 0.3%	0 0%	0 0%	1 0.3%

Outcome Measures

1. Primary Outcome

Title	Number of Primary Eyes With Distance Corrected Near Visual Acuity (DCNVA) to 20/40 or Better or Improvement of 2 or More Lines
Description	Measurement of the Distance Corrected Near Visual Acuity at 40 centimeters achieving 20/40 or better or improvement of 2 or more lines at 24 months for the primary eye.
Time Frame	From date of baseline measurement until the date of study withdrawal or study completion, whichever came first, assessed up to 2 years.

Outcome Measure Data

Analysis Population Description

Explanted primary eyes were analyzed as failures. Data for primary eyes that missed the 24 month visit, were lost to follow-up, or withdrew consent prior to the 24 month visit were not imputed. Per protocol, primary outcome analysis must be performed on the primary eye only. Fellow eye data is used for safety outcomes and summarized separately.

Arm/Group Title	Overall Study Population
Arm/Group Description	A total of 330 subjects at 11 sites received implantation of the PSI and were followed for 24 months post surgical. As per the protocol, the primary eye is the unit of analysis and was used for primary endpoint analysis. Fellow eyes were followed for safety and summarized separately. The primary eyes of subjects participating in the randomized sub-study were analyzed separately, though, they were also considered part of the overall study if they received implantation of the PSI.
Measure Participants	317
Measure Primary Eyes	317
Count of Units [Primary Eyes]	288

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Overall Study Population
	Comments	The PSI procedure is defined as successful if 75% of subjects achieve the first primary endpoint or second primary endpoint. The corresponding statistical hypotheses are as follows: H0 (null hypothesis): p1 ≤ 0.75 Ha (alternative hypothesis): p1 > 0.75, Where, p1 is the probability of subjects achieving the first primary endpoint. H0 (null hypothesis): p2 ≤ 0.75 Ha (alternative hypothesis): p2 > 0.75, Where, p2 is the probability of subjects achieving the second primary endpoint.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.025
	Comments	the p-value is adjusted for multiple comparisons
	Method	Fisher Exact
	Comments
Method of Estimation	Estimation Parameter	binomial distribution
	Estimated Value	0.75
	Confidence Interval	(1-Sided) 97.5%; 0.75 to
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Presence of Significant Safety Events (SAEs).
Description	The point estimate were calculated for clinically significant adverse events (SAE's) at the end of the study. Incidence of adverse event totals should not to exceed 5%, and the incidence of each event should not exceed 1-2%. NOTE: Because the secondary outcome is a safety measure, both primary and fellow eyes were used for analysis.
Time Frame	From initiation of the implantation procedure (operative day) until study completion at 24 months or withdrawal from the study.

Outcome Measure Data

Analysis Population Description

All subject eyes implanted with the PSI were included in the safety analysis. The point estimates were calculated for each of the following events at 24 months. Only the incidence of serious adverse events (SAE's) is presented here as only (1) secondary outcome is allowed.

Arm/Group Title	Overall Study Population
Arm/Group Description	A total of 330 subjects at 11 sites received implantation of the PSI and were followed for 24 months post surgical. For the safety analysis, subjects participating in the randomized sub-study were analyzed as part of the overall study if they received implantation of the PSI.
Measure Participants	330
Measure Primary and Fellow Eyes	645
Count of Units [Primary and Fellow Eyes]	3

3. Other Pre-specified Outcome

Title	Safety Parameter Point Estimate -- Anterior Segment Ischemia
Description	All primary and fellow eyes implanted with the PSI were included in the safety analysis. Point estimates were calculated for the incidence of Anterior Segment Ischemia at the end of the study. Incidence of adverse event totals should not to exceed 5%, and the incidence of each event should not exceed 1-2% NOTE: Because the secondary outcome is a safety measure, both primary and fellow eyes were used for analysis.
Time Frame	From initiation of the implantation procedure (operative day) until study completion at 24 months or withdrawal from the study.

Outcome Measure Data

Analysis Population Description

All subject eyes implanted with the PSI were included in the safety analysis.

Arm/Group Title	Overall Study Population
Arm/Group Description	A total of 330 subjects (645 eyes) at 11 sites received implantation of the PSI and were followed for 24 months post surgical. For the safety analysis, subjects participating in the randomized sub-study were analyzed as part of the overall study if they received implantation of the PSI.
Measure Participants	330
Measure Primary and Fellow Eyes	645
Count of Units [Primary and Fellow Eyes]	0

4. Other Pre-specified Outcome

Title	Safety Parameter Point Estimate -- Decrease in BCDVA > 2 Lines
Description	All primary and fellow eyes implanted with the PSI were included in the safety analysis. Point estimates were calculated for the incidence of Decrease in BCDVA > 2 lines at the end of the study. Incidence of adverse event totals should not to exceed 5%, and the incidence of each event should not exceed 1-2%. NOTE: Because the secondary outcome is a safety measure, both primary and fellow eyes were used for analysis.
Time Frame	From initiation of the implantation procedure (operative day) until study completion at 24 months or withdrawal from the study.

Outcome Measure Data

Analysis Population Description

All subject eyes implanted with the PSI were included in the safety analysis.

Arm/Group Title	Overall Study Population
Arm/Group Description	A total of 330 subjects (645 eyes) at 11 sites received implantation of the PSI and were followed for 24 months post surgical. For the safety analysis, subjects participating in the randomized sub-study were analyzed as part of the overall study if they received implantation of the PSI.
Measure Participants	330
Measure Primary and Fellow Eyes	645
Count of Units [Primary and Fellow Eyes]	1

5. Other Pre-specified Outcome

Title	Safety Parameter Point Estimate -- Decrease in BCNVA > 2 Lines
Description	All primary and fellow eyes implanted with the PSI were included in the safety analysis. Point estimates were calculated for the incidence of Decrease in BCNVA > 2 lines at the end of the study. Incidence of adverse event totals should not to exceed 5%, and the incidence of each event should not exceed 1-2%. NOTE: Because the secondary outcome is a safety measure, both primary and fellow eyes were used for analysis.
Time Frame	From initiation of the implantation procedure (operative day) until study completion at 24 months or withdrawal from the study.

Outcome Measure Data

Analysis Population Description

All subject eyes implanted with the PSI were included in the safety analysis.

Arm/Group Title	Overall Study Population
Arm/Group Description	A total of 330 subjects (645 eyes) at 11 sites received implantation of the PSI and were followed for 24 months post surgical. For the safety analysis, subjects participating in the randomized sub-study were analyzed as part of the overall study if they received implantation of the PSI.
Measure Participants	330
Measure Primary and Fellow Eyes	645
Count of Units [Primary and Fellow Eyes]	0

6. Other Pre-specified Outcome

Title	Safety Parameter Point Estimate -- (IOP Increase > 10 mmHg) or (IOP > 25 mmHg)
Description	All primary and fellow eyes implanted with the PSI were included in the safety analysis (i.e. both primary and fellow eyes). Point estimates were calculated for the incidence of (IOP Increase > 10 mmHg) or (IOP > 25 mmHg) at the end of the study. Incidence of adverse event totals should not to exceed 5%, and the incidence of each event should not exceed 1-2%. NOTE: Because the secondary outcome is a safety measure, both primary and fellow eyes were used for analysis.
Time Frame	From initiation of the implantation procedure (operative day) until study completion at 24 months or withdrawal from the study.

Outcome Measure Data

Analysis Population Description

All subject eyes implanted with the PSI were included in the safety analysis.

Arm/Group Title	Overall Study Population
Arm/Group Description	A total of 330 subjects (645 eyes) at 11 sites received implantation of the PSI and were followed for 24 months post surgical. For the safety analysis, subjects participating in the randomized sub-study were analyzed as part of the overall study if they received implantation of the PSI.
Measure Participants	330
Measure Primary and Fellow Eyes	645
Count of Units [Primary and Fellow Eyes]	55

7. Other Pre-specified Outcome

Title	Safety Parameter Point Estimate -- Chronic Inflammation
Description	All primary and fellow eyes implanted with the PSI were included in the safety analysis. Point estimates were calculated for the incidence of Chronic Inflammation at the end of the study. Incidence of adverse event totals should not to exceed 5%, and the incidence of each event should not exceed 1-2%. NOTE: Because the secondary outcome is a safety measure, both primary and fellow eyes were used for analysis.
Time Frame	From initiation of the implantation procedure (operative day) until study completion at 24 months or withdrawal from the study.

Outcome Measure Data

Analysis Population Description

All subject eyes implanted with the PSI were included in the safety analysis.

Arm/Group Title	Overall Study Population
Arm/Group Description	A total of 330 subjects (645 eyes) at 11 sites received implantation of the PSI and were followed for 24 months post surgical. For the safety analysis, subjects participating in the randomized sub-study were analyzed as part of the overall study if they received implantation of the PSI.
Measure Participants	330
Measure Primary and Fellow Eyes	645
Count of Units [Primary and Fellow Eyes]	4

8. Other Pre-specified Outcome

Title	Safety Parameter Point Estimate -- (Axial Length Increase >= 0.20) AND (Myopic Shift > 0.50D MRSE)
Description	All primary and fellow eyes implanted with the PSI were included in the safety analysis. Point estimates were calculated for the incidence of (Axial Length Increase >= 0.20) AND (Myopic Shift > 0.50D MRSE) at the end of the study. Incidence of adverse event totals should not to exceed 5%, and the incidence of each event should not exceed 1-2%. NOTE: Because the secondary outcome is a safety measure, both primary and fellow eyes were used for analysis.
Time Frame	From initiation of the implantation procedure (operative day) until study completion at 24 months or withdrawal from the study.

Outcome Measure Data

Analysis Population Description

All subject eyes implanted with the PSI were included in the safety analysis.

Arm/Group Title	Overall Study Population
Arm/Group Description	A total of 330 subjects (645 eyes) at 11 sites received implantation of the PSI and were followed for 24 months post surgical. For the safety analysis, subjects participating in the randomized sub-study were analyzed as part of the overall study if they received implantation of the PSI.
Measure Participants	330
Measure Primary and Fellow Eyes	645
Count of Units [Primary and Fellow Eyes]	0

Adverse Events

Time Frame	Adverse event reporting continued through 24 months.
Arm/Group Title	PresVIEW Implantation - Single Arm
Arm/Group Description	330 nonrandomized subjects entered into a single group arm to receive the PresView Scleral Implants, which were surgical placed in the sclera of the eye. Subjects were followed for 24 months.
All Cause Mortality
	PresVIEW Implantation - Single Arm
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	PresVIEW Implantation - Single Arm
	Affected / at Risk (%)	# Events
Total	3/330 (0.9%)
Eye disorders
Decreased iris perfusion	3/330 (0.9%)	3
Other (Not Including Serious) Adverse Events
	PresVIEW Implantation - Single Arm
	Affected / at Risk (%)	# Events
Total	143/330 (43.3%)
Eye disorders
Anterior Eye Structural Change, Deposit and Degeneration	21/330 (6.4%)
Eye Disorders NEC	47/330 (14.2%)
Ocular Hemorrhages and Vascular Disorders NEC	11/330 (3.3%)
Ocular Infections, Irritations and Inflammations	70/330 (21.2%)
Ocular Neoplasms	7/330 (2.1%)
Ocular Neuromuscular Disorders	4/330 (1.2%)
Ocular Sensory Symptoms NEC	8/330 (2.4%)
Ocular Structural Change, Deposit and Degeneration NEC	9/330 (2.7%)
Retina, Choroid and Vitreous Hemorrhages and Vascular Disorders	5/330 (1.5%)
Vision Disorders	1/330 (0.3%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Principal Investigators are NOT employed by the organization sponsoring the study. The Sponsor encourages publication and presentation of the safety and efficacy results upon completion of the study. Per the established agreement, the Principal Investigators will work with the Sponsor, in good faith, to ensure all confidential and proprietary information is redacted.