Trial Outcomes & Findings for Comparison of the Hoya Surgical Optics (HSO) iSert 251 Posterior Chamber Aspheric Aphakic Intraocular Lens to Historical / Literature Controls. (NCT NCT01292629)

Results Overview

BEST Spectacle-Correction (ETDRS) Distance Visual Acuity

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

125 participants

Primary outcome timeframe

4 to 6 months

Results posted on

2015-03-20

Participant Flow

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.

Subject's eligibility was determined at the preoperative visit. All subject met inclusion/exclusion criteria.

Participant milestones

Participant milestones
Measure	iSert 251: iSert 251 Intraocular Lens Implantation with the iSert® 251 Intraocular lens
Overall Study STARTED	125
Overall Study COMPLETED	125
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	iSert® 251 Intraocular Lens n=125 Participants Population Description: A total of 125 subjects were implanted with the iSert® IOL. Data analysis for baseline characteristics was completed on these 125 subjects.
Age, Customized < 60 years of age	7 participants n=5 Participants
Age, Customized 61 - 69 years of age	50 participants n=5 Participants
Age, Customized 70 - 79 years of age	53 participants n=5 Participants
Age, Customized ≥ 80 years of age	15 participants n=5 Participants
Sex/Gender, Customized Female	77 participants n=5 Participants
Sex/Gender, Customized Male	48 participants n=5 Participants

PRIMARY outcome

Timeframe: 4 to 6 months

Population: 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.

BEST Spectacle-Correction (ETDRS) Distance Visual Acuity

Outcome measures

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

SECONDARY outcome

Timeframe: 4 to 6 months

Number of Participants with Complications or Adverse Events

Outcome measures

Outcome measures
Measure	iSert 251: iSert 251 Intraocular Lens n=125 Participants Eligible subjects underwent phacoemulsification cataract extraction surgery and were implanted with the iSert® Intraocular Lens. Study observation was up to 271 days.
Complications and Adverse Events	0 participants

Adverse Events

iSert 251: iSert 251 Intraocular Lens

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Kees den Besten, Vice President Global Quality, Regulatory Affairs, and Clinical Research

Hoya Surgical Optics, Inc.

Phone: +65 6681 0025

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place