Clinical Investigation of a Small Aperture Extended Depth of Focus Intraocular Lens in Patients With Complex Corneas

Status: Completed
Location: See all (2) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The objective of this study is to evaluate the clinical outcomes of the IC-8 IOL implanted in patients with complex corneas after crystalline lens removal.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 22
Healthy Volunteers: t
View:

• 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);

• Planned crystalline lens removal by phacoemulsification, with or without femtosecond laser-assisted extraction, and posterior chamber IOL implantation;

• Planned cataract removal or planned clear lens exchange in both eyes

• Potential for postoperative best-corrected distance visual acuity (BCDVA) of 20/32 or better after crystalline lens removal;

• Having complex corneas with irregular astigmatism

• Having clear central cornea

• Having best-corrected distance visual acuity (BCDVA) or 20/40 or worse in either eye with or without a glare source (patients with bilateral cataract).

Locations
Other Locations
Philippines
Asian Eye Institute
Makati City
Singapore
Singapore National Eye Centre (SNEC); Singapore Eye Research Institute (SERI)
Singapore
Time Frame
Start Date: 2022-07-12
Completion Date: 2024-11-28
Participants
Target number of participants: 45
Treatments
Experimental: IC-8 IOL Group
A monofocal or monofocal toric IOL implanted in the first eye of a subject and the IC-8 IOL implanted in the second eye.
Related Therapeutic Areas
Sponsors
Leads: AcuFocus, Inc.

This content was sourced from clinicaltrials.gov