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

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.

Study Overview

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

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 Type: Observational
• Enrollment (Actual): 21

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore
    • Singapore Eye Research Institute / Singapore National Eye Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Patients for this study will be recruited from patients with complex corneas who have been previously implanted with the IC-8 IOL after cataract removal. Anticipated study sample size of up to 40 patients will be evaluated.

Patients will be screened for eligibility, and an informed consent will be obtained from those who meet the screening criteria and are interested in participating in the study.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
IC-8 IOL Group; Visual outcomes in patients previously contralaterally implanted with the IC-8 IOL will be evaluated.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: AcuFocus, Inc.
• Investigators: Study Director: Magda Michna, Ph.D., AcuFocus, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): February 10, 2022
• Primary Completion (Actual): December 30, 2022
• Study Completion (Actual): December 30, 2022

Study Registration Dates

• First Submitted: May 12, 2022
• First Submitted That Met QC Criteria: May 12, 2022
• First Posted (Actual): May 17, 2022

Study Record Updates

• Last Update Posted (Actual): May 10, 2023
• Last Update Submitted That Met QC Criteria: May 9, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Refractive Errors; Cataract; Presbyopia; Corneal Diseases
• Other Study ID Numbers: IC8-303-EXPA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No