Clinical Investigation iDesign System With 1.3-PRESBY Treatment and STAR S4 IR™ Excimer Laser System

• Sponsor: Abbott Medical Optics (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT02806726
• Collaborator: (none)
• Enrollment: 42
• Locations: 3
• Arms: 2
• Actual Duration (Months): 15.9
• Patients Per Site: 14
• Patients Per Site Per Month: 0.9

Study Details

Study Description

Brief Summary

A prospective study to evaluate the feasibility of a new treatment algorithm to increase depth of focus after wavefront-guided LASIK correction of myopic refractive errors with the iDesign Advanced Wavescan Studio™ System and Star S4 IR™ Excimer Laser System. The purpose of this study is to determine whether wavefront-guided LASIK correction of myopic refractive errors with CustomVue combined with iDesign 1.3-PRESBY (presbyT-LASIK) treatments mitigate the effects of presbyopia by increasing the depth of focus compared to iDesign CustomVue treatments.

Condition or Disease	Intervention/Treatment	Phase
Presbyopia; Myopia	Device: iDesign 1.3-PRESBY treatment; Device: iDesign 1.3 treatment	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 42 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Prospective Study to Evaluate the Feasibility of a New Treatment Algorithm to Increase Depth of Focus After Wavefront-guided LASIK Correction of Myopic Refractive Errors With the iDesign System and Star S4 IR™ Excimer Laser System
• Actual Study Start Date: Jul 13, 2016
• Actual Primary Completion Date: Nov 9, 2017
• Actual Study Completion Date: Nov 9, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: iDesign 1.3-PRESBY iDesign 1.3-PRESBY in one eye of subject (experimental) is used to calculate the LASIK treatment profile for the iDesign Advanced Wavescan Studio™ System within the Star S4 IR™ Excimer Laser System.	Device: iDesign 1.3-PRESBY treatment; Software used to calculate the LASIK treatment profile including a presbyopic correction component for the iDesign Advanced Wavescan Studio™ System within the Star S4 IR™ Excimer Laser System.
Active Comparator: iDesign 1.3 iDesign 1.3 in one eye of subject (control) is used to calculate the LASIK treatment profile for the iDesign Advanced Wavescan Studio™ System within the Star S4 IR™ Excimer Laser System.	Device: iDesign 1.3 treatment; Software used to calculate the LASIK treatment profile for the iDesign Advanced Wavescan Studio™ System within the Star S4 IR™ Excimer Laser System.

Outcome Measures

Primary Outcome Measures

1. Monocular Distance Corrected Intermediate Visual Acuity (DCIVA) at 67 cm [6 months]

   Mean distance corrected intermediate visual acuity (DCIVA) for presbyT-LASIK treatments (test) was compared to iDesign CustomVue treatments (control).

Secondary Outcome Measures

1. Monocular Distance Corrected Near Visual Acuity (DCNVA) AT 40 cm [6 months]

   Mean distance corrected near visual acuity (DCNVA) for PresbyT-LASIK treatments (test) was compared to iDesign CustomVue treatments (control).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 45 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

All criteria apply to each eye

1. Signed informed consent and Personal Health Information Protection Act authorization.

2. At least 45 years of age at enrollment (date informed consent signed).

3. The refractive error, based on the iDesign displayed refraction selected for treatment ("4.0 Rx calc" at 12.5 mm), must be myopia with or without astigmatism with sphere up to -6.00 D, and cylinder between 0.00 D and -5.00 D with a maximum spherical equivalent (SE) of -8.00 D.

4. Require an add power of +1.00 D or more during near testing at 40 cm.

5. Anticipated stromal bed thickness of at least 250 microns based on preoperative central corneal pachymetry minus the maximum ablation depth (as calculated by the iDesign system) plus the intended flap thickness.

6. Distance Best Spectacle Corrected Visual Acuity (BSCVA) of 20/20 or better.

7. Uncorrected Visual Acuity (UCVA) of 20/40 or worse.

8. Less than or equal to 0.75 D difference between cycloplegic and manifest refraction sphere.

9. A stable refractive error (based on a previous exam, medical records, lensometry, or prescription at least 12 months prior to the preoperative manifest refraction), as defined by a change of ≤1.00 D in MRSE.

10. Any eye with a history of contact lens wear within the last 4 weeks must demonstrate refractive stability according to the following:

11. Rigid contact lenses (toric or spherical) must be removed for at least 4 weeks and soft contact lenses (toric or spherical) for at least 2 weeks prior to the first refraction used to establish stability.

12. Two consecutive refractions and keratometric readings must be conducted at least 7 days apart.

13. Refractive stability is defined as a change of not more than 0.50 D in manifest refraction sphere and cylinder as well as mean keratometry between measurements.

14. If the subject/eye meets the refractive stability criteria, contact lens wear is not permitted prior to surgery.

15. Agreement between manifest refraction (adjusted for optical infinity) and iDesign

System refraction chosen for treatment, as follows:

1. Spherical Equivalent: Magnitude of the difference is less than 0.625 D.

2. Cylinder: Magnitude of the difference is less than or equal to 0.5 D.

3. Cylinder Axis Tolerance: If either the manifest cylinder entered into the iDesign System or the iDesign cylinder selected for treatment is less than 0.5 D, there is no requirement for axis tolerance. When both cylinders have a magnitude of at least 0.5 D, the axis tolerance as determined by the iDesign system is linearly reduced from 15 (0.5 D) to 7.5 (7.0 D) based on the average magnitude of both cylinders. Note: If the axis tolerance is not in the calculated range, the iDesign system will produce a warning and this exam may not be used for treatment planning.

4. Willing and capable of complying with follow-up examinations for the duration of the study.

Exclusion Criteria:

1. Women who are pregnant, breast-feeding, intend to become pregnant, or are not using an adequate method of birth control [examples are any form of barrier contraception (such as condom or diaphragm with contraceptive cream/jelly), birth control pills, hormonal implant, IUD, abstinence or surgical sterilization (tubal ligation, hysterectomy or vasectomy)]. Note: Women who were pregnant or nursing may not be enrolled until 6 months after either delivery or have stopped nursing and there is documented refractive stability.

2. Concurrent use of systemic (including inhaled) medications that may impair healing, including but not limited to: antimetabolites, isotretinoin (Accutane®) within 6 months of treatment, and amiodarone hydrochloride (Cordarone®) within 12 months of treatment.

NOTE: The use of inhaled or systemic corticosteroids, whether chronic or acute, is deemed to adversely affect healing and subjects using such medications are specifically excluded from eligibility.

1. History of any of the following medical conditions, or any other condition that could affect wound healing: collagen vascular disease, autoimmune disease, immunodeficiency diseases, ocular herpes zoster or herpes simplex, endocrine disorders (including, but not limited to unstable thyroid disorders and diabetes), lupus, and rheumatoid arthritis.

NOTE: The presence of diabetes (either type 1 or 2), regardless of disease duration, severity, or control, will specifically exclude subjects from eligibility.

1. Subjects with a cardiac pacemaker, implanted defibrillator or other implanted electronic device.

2. History of prior intraocular or corneal surgery (including cataract extraction), active ophthalmic disease or abnormality (including, but not limited to, symptomatic blepharitis, recurrent corneal erosion, dry eye syndrome, neovascularization > 1 mm from limbus), retinal detachment/repair, clinically significant lens opacity, clinical evidence of trauma, corneal opacity within the central 9 mm and visible on topography, at risk for developing strabismus, or with evidence of glaucoma or propensity for narrow angle glaucoma.

NOTE: Subjects with open angle glaucoma, regardless of medication regimen or control, or an IOP greater than 21 mmHg at screening, are specifically excluded from eligibility.

1. Evidence of keratoconus, corneal dystrophy or irregularity, or abnormal topography.

2. Known sensitivity or inappropriate responsiveness to any of the medications used in the postoperative course.

3. Desire to have monovision.

4. Intolerance to multifocal correction based on questionnaire responses to contact lens trial.

5. Participation in any other clinical study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Image Plus Laser Eye Center	Winnipeg	Manitoba	Canada	R3C3J5
2	University of Ottawa	Ottawa	Ontario	Canada	K1H 8L6
3	Crystal Clear Vision	Toronto	Ontario	Canada	M5R 2E3

Sponsors and Collaborators

• Abbott Medical Optics

Investigators

• Study Director: Kendra Hileman, Abbott Medical Optics

Study Documents (Full-Text)

• Study Protocol - Nov 8, 2016
• Statistical Analysis Plan - Nov 10, 2015

More Information

Publications

None provided.

• Responsible Party: Abbott Medical Optics
• ClinicalTrials.gov Identifier: NCT02806726
• Other Study ID Numbers: STAR-116-TOPS
• First Posted: Jun 21, 2016
• Last Update Posted: Feb 8, 2019
• Last Verified: Feb 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes
• Additional relevant MeSH terms: Presbyopia

Study Results

Participant Flow

Pre-assignment Detail	Per the protocol, the total number of participants enrolled is 42 (the number of participants who agreed to participate in the study and completed the informed consent process). The total number of participants Started is 7 (the number of participants who were assigned to each Arm/Group).

Arm/Group Title	All Study Participants
Arm/Group Description	Parts of a participant were allocated to different interventions: Left side iDesign 1.3-PRESBY, Right side iDesign 1.3 Left Side iDesign 1.3, Right Side iDesign 1.3-PRESBY
Period Title: Overall Study
STARTED	7
COMPLETED	6
NOT COMPLETED	1

Baseline Characteristics

Arm/Group Title	All Study Participants
Arm/Group Description	Parts of a participant were allocated to different interventions: Left side iDesign 1.3-PRESBY, Right side iDesign 1.3 Left Side iDesign 1.3, Right Side iDesign 1.3-PRESBY
Overall Participants	7
Overall Eyes	14
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	49.2 (3.3)
Sex: Female, Male (Count of Participants)
Female	4 57.1%
Male	3 42.9%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	1 14.3%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	0 0%
White	6 85.7%
More than one race	0 0%
Unknown or Not Reported	0 0%

Outcome Measures

1. Primary Outcome

Title	Monocular Distance Corrected Intermediate Visual Acuity (DCIVA) at 67 cm
Description	Mean distance corrected intermediate visual acuity (DCIVA) for presbyT-LASIK treatments (test) was compared to iDesign CustomVue treatments (control).
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

Due to the small sample size, descriptive results for all endpoints are provided along with confidence intervals, and no statistical conclusions are made.

Arm/Group Title	iDesign 1.3-Presby Treatment (Experimental)	iDesign CustomVue Treatments (Control)
Arm/Group Description	One of subject's eye (experimental) treated with wavefront-guided LASIK correction of myopic refractive errors with the iDesign Advanced Wavescan Studio™ System with iDesign 1.3-PRESBY (presbyT-LASIK) treatments	One of subject's eye (control) treated with wavefront-guided LASIK correction of myopic refractive errors with the iDesign Advanced Wavescan Studio™ System with iDesign CustomVue treatments
Measure Participants	6	6
Measure Eyes	6	6
Mean (95% Confidence Interval) [LogMAR]	0.03	0.1

2. Secondary Outcome

Title	Monocular Distance Corrected Near Visual Acuity (DCNVA) AT 40 cm
Description	Mean distance corrected near visual acuity (DCNVA) for PresbyT-LASIK treatments (test) was compared to iDesign CustomVue treatments (control).
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

Due to the small sample size, descriptive results for all endpoints are provided along with confidence intervals, and no statistical conclusions are made.

Arm/Group Title	iDesign 1.3-Presby Treatment (Experimental)	iDesign CustomVue Treatments (Control)
Arm/Group Description	One of subject's eye (experimental) treated with wavefront-guided LASIK correction of myopic refractive errors with the iDesign Advanced Wavescan Studio™ System with iDesign 1.3-PRESBY (presbyT-LASIK) treatments	One of subject's eye (control) treated with wavefront-guided LASIK correction of myopic refractive errors with the iDesign Advanced Wavescan Studio™ System with iDesign CustomVue treatments
Measure Participants	6	6
Measure Eyes	6	6
Mean (95% Confidence Interval) [LogMar]	0.25	0.35

Adverse Events

Time Frame	6 months
Arm/Group Title	All Study Participants
Arm/Group Description	Parts of a participant were allocated to different interventions: Left side iDesign 1.3-PRESBY, Right side iDesign 1.3 Left Side iDesign 1.3, Right Side iDesign 1.3-PRESBY
All Cause Mortality
	All Study Participants
	Affected / at Risk (%)	# Events
Total	0/7 (0%)
Serious Adverse Events
	All Study Participants
	Affected / at Risk (%)	# Events
Total	0/7 (0%)
Other (Not Including Serious) Adverse Events
	All Study Participants
	Affected / at Risk (%)	# Events
Total	2/7 (28.6%)
Eye disorders
Diffuse lamellar keratitis	1/7 (14.3%)
General disorders
Mild Headache	1/7 (14.3%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results.