CompletedNot Applicable

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

Singapore21 participantsStarted 2022-02-10

Plain-language summary

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.

Who can participate

Age range22 Years

SexALL

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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;

What they're measuring

Monocular UCDVA

Timeframe: 3 Months

Monocular UCIVA

Timeframe: 3 Months

Monocular UCNVA

Timeframe: 3 Months

Trial details

NCT IDNCT05377515

SponsorAcuFocus, Inc.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2022-12-30

View on ClinicalTrials.gov More Cataract trials