Evaluation of Visual Outcomes in Patients With Complex Corneas Implanted With the IC-8 IOL

Study Overview
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Brief Summary
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The purpose of this study is to evaluate visual outcomes in patients with complex corneas who have been previously implanted with the IC-8 IOL after cataract removal.

Detailed Description
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This will be a prospective, non-randomized, single-arm, single-visit, single-center, clinical study in up to 40 patients previously contralaterally implanted with the IC-8 IOL at one clinical site in Singapore. The purpose of this study is to to evaluate visual outcomes in patients with complex corneas who have been previously implanted with the IC-8 IOL after cataract removal. The co-primary study endpoints are monocular uncorrected distance, intermediate, near visual acuities.

Official Title
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Evaluation of Visual Outcomes in Patients With Complex Corneas Implanted With the IC-8 IOL

Conditions
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Cataract, Presbyopia, Irregular; Contour of Cornea

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Minimum 22 years of age; Able to comprehend and have signed a statement of informed consent; Availability, willingness, ability and sufficient cognitive awareness to comply with examination procedures and study visit(s); Having complex corneas prior to cataract surgery; Previous cataract surgery and IC-8 IOL implantation in the eye (implanted for 3 months or longer prior to study participation). Exclusion Criteria: Baseline visual acuity worse than 20/25 BCDVA in either eye; Presence of ocular abnormalities or conditions other than corneal irregularities that could confound the study outcome(s), such as: Strabismus or amblyopia Retinal or macular abnormalities Recurrent and/or persistent ocular inflammation Known pathology that may affect visual acuity to a level worse than 20/25 BCDVA Previous intraocular surgery, except cataract surgery, pterygium surgery, or corneal procedures (other than corneal-cross linking); Previous corneal cross-linking procedure with any corneal haze; Conditions requiring planned ocular surgical intervention, except Nd:YAG capsulotomy; Severe dry eye or other conditions (such as hormonal fluctuations) that could lead to unstable refraction and/or visual acuity measurements or eye discomfort even with ocular lubricants or dry eye medication; Patient is pregnant or nursing.

Ages Eligible for Study
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Minimum Age: 22 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| IC-8 IOL Group<br>Visual outcomes in patients previously contralaterally implanted with the IC-8 IOL will be evaluated. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Monocular UCDVA | 0.3 logMAR or better | 3 Months | 
| Monocular UCIVA | 0.3 logMAR or better | 3 Months | 
| Monocular UCNVA | not worse than 0.3 logMAR | 3 Months |