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)
125
Enrollment
5
Locations
1
Arm
14.9
Duration (Months)
25
Patients Per Site
1.7
Patients Per Site Per Month

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 DiseaseIntervention/TreatmentPhase
  • 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

ArmIntervention/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

SiteCityStateCountryPostal Code
1Schwartz Laser Eye CenterE. Shea Blvd, Suite C101ArizonaUnited States85260
2Katzen Eye Care and Laser CenterBoynton BeachFloridaUnited States33426
3Center for Excellence in Eye CareMiamiFloridaUnited States33176
4Eye Surgeons of IndianaIndianapolisIndianaUnited States46256
5Eye Health Vision CentersNorth DartmouthMassachusettsUnited States02747

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.
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment DetailsSubjects 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 DetailSubject's eligibility was determined at the preoperative visit. All subject met inclusion/exclusion criteria.
Arm/Group TitleiSert 251: iSert 251 Intraocular Lens
Arm/Group DescriptionImplantation with the iSert® 251 Intraocular lens
Period Title: Overall Study
STARTED125
COMPLETED125
NOT COMPLETED0

Baseline Characteristics

Arm/Group TitleiSert® 251 Intraocular Lens
Arm/Group DescriptionPopulation Description: A total of 125 subjects were implanted with the iSert® IOL. Data analysis for baseline characteristics was completed on these 125 subjects.
Overall Participants125
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
TitleVisual Acuity
DescriptionBEST Spectacle-Correction (ETDRS) Distance Visual Acuity
Time Frame4 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 TitleiSert 251: iSert 251 Intraocular Lens
Arm/Group DescriptionEligible subjects underwent phacoemulsification cataract extraction surgery and were implanted with the iSert® Intraocular Lens. Study observation was up to 271 days.
Measure Participants121
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
TitleComplications and Adverse Events
DescriptionNumber of Participants with Complications or Adverse Events
Time Frame4 to 6 months

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group TitleiSert 251 Aphakik IOL
Arm/Group DescriptioniSert 251: iSert 251 intraocular lens
Measure Participants125
Number [participants]
0
0%

Adverse Events

Time Frame4-6 months
Adverse Event Reporting Description
Arm/Group TitleiSert 251: iSert 251 Intraocular Lens
Arm/Group DescriptionSubjects 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
Total0/125 (0%)
Other (Not Including Serious) Adverse Events
iSert 251: iSert 251 Intraocular Lens
Affected / at Risk (%)# Events
Total0/125 (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.

Results Point of Contact

Name/TitleKees den Besten, Vice President Global Quality, Regulatory Affairs, and Clinical Research
OrganizationHoya Surgical Optics, Inc.
Phone+65 6681 0025
Emailkees.denbesten@HOYA.com
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