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

NCT05377515 | Completed

• 1 other identifier: IC8-303-EXPA
• Study Type: observational
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Cataract; Presbyopia; Irregular; Contour of Cornea

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

IC-8 IOL Group

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

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• AcuFocus, Inc.: lead

Study Sites (1)

Singapore Eye Research Institute / Singapore National Eye Centre

Singapore, Singapore

Location

MeSH Terms

Conditions

Cataract; Presbyopia

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases; Refractive Errors

Study Officials

• Magda Michna, Ph.D.

  AcuFocus, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2022
• First Posted: May 17, 2022
• Study Start: February 10, 2022
• Primary Completion: December 30, 2022
• Study Completion: December 30, 2022
• Last Updated: May 10, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)