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 range

22 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

Who can participate

Age range

22 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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