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

Not Applicable

Completed

• Conditions: Presbyopia; Cataract; Irregular Astigmatism
• Interventions: Device: IC-8 Intraocular Lens (IOL)

• Registration Number: NCT05574270
• Lead Sponsor: AcuFocus, Inc.

Brief 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.

Detailed Description

This is a prospective, multi-center, open-label, non-randomized, single-arm clinical investigation with planned postoperative follow-up of 4-6 months. The monocular and binocular performance of the subjects will be evaluated.

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.

The co-primary effectiveness endpoints are monocular uncorrected distance, intermediate, and near visual acuities at 4-6 Months postoperative. The primary safety endpoint is best-corrected distance visual acuity at 4-6 Months postoperative. The secondary safety endpoint is photopic and mesopic contrast sensitivity at 4-6 Months postoperative.

Study Timeline

• Study Start: 2022-07-12
• Study First Submitted: 2022-10-07
• Study First Submitted QC: 2022-10-07
• Study First Posted: 2022-10-10
• Primary Completion: 2024-11-28
• Study Completion: 2024-11-28
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-17
• Last Update Posted: 2024-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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. Planned crystalline lens removal by phacoemulsification, with or without femtosecond laser-assisted extraction, and posterior chamber IOL implantation;
5. Planned cataract removal or planned clear lens exchange in both eyes
6. Potential for postoperative best-corrected distance visual acuity (BCDVA) of 20/32 or better after crystalline lens removal;
7. Having complex corneas with irregular astigmatism
8. Having clear central cornea
9. 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).

Exclusion Criteria

1. Requiring an IC-8 IOL outside the available spherical power range;
2. Pharmacologically dilated pupil size less than 6 mm in either eye;
3. Preoperative corneal astigmatism >1.50 diopters in the eye to be implanted with the IC-8 IOL;
4. Active or recurrent anterior segment pathology;
5. Presence of ocular abnormalities or conditions (other than corneal irregularities) as specified by the protocol;
6. Congenital bilateral cataracts;
7. Previous ocular surgery as specified by the protocol;
8. Conditions requiring planned ocular surgical intervention;
9. 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;
10. Use of systemic or ocular medications as specified by the protocol;
11. Concurrent participation or participation in any clinical investigation up to 30 days prior to preoperative visit;
12. Patient is pregnant or nursing.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
IC-8 IOL Group	IC-8 Intraocular Lens (IOL)	A monofocal or monofocal toric IOL implanted in the first eye of a subject and the IC-8 IOL implanted in the second eye.

Primary Outcome Measures

Name	Time	Method
Monocular best-corrected distance visual acuity (BCDVA) in the IC-8 IOL eye	4-6 Months	Mean best-corrected distance visual acuity (BCDVA) in the IC-8 IOL eye at 4-6 Months is not statistically worse than 0.2 logMAR
Monocular uncorrected intermediate visual acuity (UCIVA)	4-6 Months	Mean acuity from the IC-8 IOL eye at 4-6 Months is statistically better compared to preoperative
Monocular uncorrected distance visual acuity (UCDVA)	4-6 Months	Mean acuity from the IC-8 IOL eye at 4-6 Months is statistically better compared to preoperative
Monocular uncorrected near visual acuity (UCNVA)	4-6 Months	Mean acuity from the IC-8 IOL eye at 4-6 Months is statistically better compared to preoperative

Secondary Outcome Measures

Name	Time	Method
Monocular and Binocular Contrast Sensitivity	4-6 Months	Photopic and Mesopic contrast sensitivity (with and without glare) in each eye and both eyes will be analyzed. No success criterion or hypothesis testing.

Trial Locations

Locations (2)

Asian Eye Institute; 🇵🇭 Makati City, Philippines

Singapore National Eye Centre (SNEC); Singapore Eye Research Institute (SERI); 🇸🇬 Singapore, Singapore