Status:
COMPLETED
Evaluation of Visual Outcomes in Patients With Complex Corneas Implanted With the IC-8 IOL
Lead Sponsor:
AcuFocus, Inc.
Conditions:
Cataract
Presbyopia
Eligibility:
All Genders
22+ years
Brief 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.
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 10 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 30 2022
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT05377515
Start Date
February 10 2022
End Date
December 30 2022
Last Update
May 10 2023
Active Locations (1)
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1
Singapore Eye Research Institute / Singapore National Eye Centre
Singapore, Singapore