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

Completed

• Conditions: Cataract; Irregular; Contour of Cornea; Presbyopia

• Registration Number: NCT05377515
• Lead Sponsor: AcuFocus, Inc.

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 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.

Study Timeline

• Study Start: 2022-02-10
• Study First Submitted: 2022-05-12
• Study First Submitted QC: 2022-05-12
• Study First Posted: 2022-05-17
• Primary Completion: 2022-12-30
• Study Completion: 2022-12-30
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-09
• Last Update Posted: 2023-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

1. Minimum 22 years of age;
2. Able to comprehend and have signed a statement of informed consent;
3. Availability, willingness, ability and sufficient cognitive awareness to comply with examination procedures and study visit(s);
4. Having complex corneas prior to cataract surgery;
5. Previous cataract surgery and IC-8 IOL implantation in the eye (implanted for 3 months or longer prior to study participation).

Exclusion Criteria

1. Baseline visual acuity worse than 20/25 BCDVA in either eye;

2. Presence of ocular abnormalities or conditions other than corneal irregularities that could confound the study outcome(s), such as:

   1. Strabismus or amblyopia
   2. Retinal or macular abnormalities
   3. Recurrent and/or persistent ocular inflammation
   4. Known pathology that may affect visual acuity to a level worse than 20/25 BCDVA

3. Previous intraocular surgery, except cataract surgery, pterygium surgery, or corneal procedures (other than corneal-cross linking);

4. Previous corneal cross-linking procedure with any corneal haze;

5. Conditions requiring planned ocular surgical intervention, except Nd:YAG capsulotomy;

6. 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;

7. Patient is pregnant or nursing.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Monocular UCNVA	3 Months	not worse than 0.3 logMAR
Monocular UCDVA	3 Months	0.3 logMAR or better
Monocular UCIVA	3 Months	0.3 logMAR or better

Trial Locations

Locations (1)

Singapore Eye Research Institute / Singapore National Eye Centre; 🇸🇬 Singapore, Singapore