Comparison of the Hoya Surgical Optics (HSO) iSert 251 Posterior Chamber Aspheric Aphakic Intraocular Lens to Historical / Literature Controls.

• Sponsor: Hoya Surgical Optics, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01292629
• Collaborator: (none)
• Enrollment: 125
• Locations: 5
• Arm: 1
• Duration (Months): 14.9
• Patients Per Site: 25
• Patients Per Site Per Month: 1.7

Study Details

Study Description

Brief Summary

The purpose of this multi-center clinical trail is to determine the safety and efficacy of the iSert 251 for the correction of aphakia.

Condition or Disease	Intervention/Treatment	Phase
Aphakia; Cataract	Device: iSert 251 intraocular lens	N/A

Detailed Description

This study evaluated the safety and effectiveness of the Hoya Surgical Optics iSert Model 251 IOL following primary implantation for the visual correction of aphakia in adults in whom the cataractous lens has been removed by phacoemulsification. Results from this prospective, multicenter clinical trial will be used to support a PMA supplement for the iSert® 251 IOL.

Study Design

• Study Type: Interventional
• Actual Enrollment: 125 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Comparison of the HSO iSert 251 Posterior Chamber Aspheric Aphakic Intraocular Lens to Historical / Literature Controls.
• Study Start Date: Feb 1, 2011
• Actual Primary Completion Date: May 1, 2012
• Actual Study Completion Date: May 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Investigational intraocular lens iSert 251 intraocular lens	Device: iSert 251 intraocular lens; aphakic intraocular lens

Outcome Measures

Primary Outcome Measures

1. Visual Acuity [4 to 6 months]

   BEST Spectacle-Correction (ETDRS) Distance Visual Acuity

Secondary Outcome Measures

1. Complications and Adverse Events [4 to 6 months]

   Number of Participants with Complications or Adverse Events

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Have been diagnosed with cataract for which phacoemulsification extraction and posterior chamber IOL implantation is indicated

• Have clear intraocular media

• Have potential Best Corrected Visual Acuity of 20/40 or better

• Have preoperative Best Spectacle-Corrected visual acuity of 20/40 or worse

Exclusion Criteria:

• Have ocular pathology or abnormalities that do or are expected to reduce best corrected visual acuity in the operative eye during the study period

• Are monocular

• Have current ocular infection

• Are taking systemic steroids or other anti-metabolites

• Have previous retinal detachment in the operative eye or expect to require retinal laser treatment during the course of the study

Eligibility criteria not complete. Contact Hoya Surgical Optics, Inc. for more information.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Schwartz Laser Eye Center	E. Shea Blvd, Suite C101	Arizona	United States	85260
2	Katzen Eye Care and Laser Center	Boynton Beach	Florida	United States	33426
3	Center for Excellence in Eye Care	Miami	Florida	United States	33176
4	Eye Surgeons of Indiana	Indianapolis	Indiana	United States	46256
5	Eye Health Vision Centers	North Dartmouth	Massachusetts	United States	02747

Sponsors and Collaborators

• Hoya Surgical Optics, Inc.

Investigators

• Study Director: Kees den Besten, Hoya Surgical Optics

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hoya Surgical Optics, Inc.
• ClinicalTrials.gov Identifier: NCT01292629
• Other Study ID Numbers: 2010-N251
• First Posted: Feb 9, 2011
• Last Update Posted: Mar 20, 2015
• Last Verified: Mar 1, 2015

• Keywords provided by Hoya Surgical Optics, Inc.: intraocular lens; IOL; cataract; Hoya; surgical; optics; ocular; visual acuity
• Additional relevant MeSH terms: Cataract; Aphakia

Study Results

Participant Flow

Recruitment Details	Subjects who were >50 years of age, either sex, and any race were eligible for this study. Diagnosis of cataracts in one or both eyes.
Pre-assignment Detail	Subject's eligibility was determined at the preoperative visit. All subject met inclusion/exclusion criteria.

Arm/Group Title	iSert 251: iSert 251 Intraocular Lens
Arm/Group Description	Implantation with the iSert® 251 Intraocular lens
Period Title: Overall Study
STARTED	125
COMPLETED	125
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	iSert® 251 Intraocular Lens
Arm/Group Description	Population Description: A total of 125 subjects were implanted with the iSert® IOL. Data analysis for baseline characteristics was completed on these 125 subjects.
Overall Participants	125
Age, Customized (participants) [Number]
< 60 years of age	7 5.6%
61 - 69 years of age	50 40%
70 - 79 years of age	53 42.4%
≥ 80 years of age	15 12%
Sex/Gender, Customized (participants) [Number]
Female	77 61.6%
Male	48 38.4%

Outcome Measures

1. Primary Outcome

Title	Visual Acuity
Description	BEST Spectacle-Correction (ETDRS) Distance Visual Acuity
Time Frame	4 to 6 months

Outcome Measure Data

Analysis Population Description

125 subjects enrolled in the study, 121 were examined at the Form 4 and the remaining four (3.2%) subjects missed the Form 4 visit but were examined later. 121 subjects were evaluated for primary and secondary effectiveness and safety outcomes.

Arm/Group Title	iSert 251: iSert 251 Intraocular Lens
Arm/Group Description	Eligible subjects underwent phacoemulsification cataract extraction surgery and were implanted with the iSert® Intraocular Lens. Study observation was up to 271 days.
Measure Participants	121
Subjects with BSCVA 20/40 or Better at Visit 3	121
Subjects with BSCVA 20/40 or Better at Visit 4	121

2. Secondary Outcome

Title	Complications and Adverse Events
Description	Number of Participants with Complications or Adverse Events
Time Frame	4 to 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	iSert 251 Aphakik IOL
Arm/Group Description	iSert 251: iSert 251 intraocular lens
Measure Participants	125
Number [participants]	0 0%

Adverse Events

Time Frame	4-6 months
Arm/Group Title	iSert 251: iSert 251 Intraocular Lens
Arm/Group Description	Subjects who underwent phacoemulsification cataract extraction surgery who were implanted with the iSert aphakic intraocular lens.
All Cause Mortality
	iSert 251: iSert 251 Intraocular Lens
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	iSert 251: iSert 251 Intraocular Lens
	Affected / at Risk (%)	# Events
Total	0/125 (0%)
Other (Not Including Serious) Adverse Events
	iSert 251: iSert 251 Intraocular Lens
	Affected / at Risk (%)	# Events
Total	0/125 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.