Aphakia, Cataract
Conditions
Keywords
intraocular lens, IOL, cataract, Hoya, surgical, optics, ocular, visual acuity
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.
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.
Interventions
DEVICEiSert 251 intraocular lens
aphakic intraocular lens
Sponsors
Hoya Surgical Optics, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Acuity | 4 to 6 months | BEST Spectacle-Correction (ETDRS) Distance Visual Acuity |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complications and Adverse Events | 4 to 6 months | Number of Participants with Complications or Adverse Events |
Countries
United States
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 details
Subject's eligibility was determined at the preoperative visit. All subject met inclusion/exclusion criteria.
Participants by arm
| Arm | Count |
|---|---|
| iSert® 251 Intraocular Lens Population Description: A total of 125 subjects were implanted with the iSert® IOL. Data analysis for baseline characteristics was completed on these 125 subjects. | 125 |
| Total | 125 |
Baseline characteristics
| Characteristic | iSert® 251 Intraocular Lens |
|---|---|
| Age, Customized < 60 years of age | 7 participants |
| Age, Customized 61 - 69 years of age | 50 participants |
| Age, Customized 70 - 79 years of age | 53 participants |
| Age, Customized ≥ 80 years of age | 15 participants |
| Sex/Gender, Customized Female | 77 participants |
| Sex/Gender, Customized Male | 48 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 125 |
| serious Total, serious adverse events | 0 / 125 |
Outcome results
Primary
Visual Acuity
BEST Spectacle-Correction (ETDRS) Distance Visual Acuity
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| iSert 251: iSert 251 Intraocular Lens | Visual Acuity | Subjects with BSCVA 20/40 or Better at Visit 3 | 121 subjects |
| iSert 251: iSert 251 Intraocular Lens | Visual Acuity | Subjects with BSCVA 20/40 or Better at Visit 4 | 121 subjects |
Secondary
Complications and Adverse Events
Number of Participants with Complications or Adverse Events
Time frame: 4 to 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| iSert 251: iSert 251 Intraocular Lens | Complications and Adverse Events | 0 participants |