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

NCT ID: NCT05574270

Last Updated: 2024-12-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-12
• Study Completion Date: 2024-11-28

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.

Conditions

Cataract; Presbyopia; Irregular Astigmatism

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

IC-8 Intraocular Lens (IOL)

Intervention Type: DEVICE

A small aperture extended depth of focus hydrophobic acrylic intraocular lens.

Interventions

IC-8 Intraocular Lens (IOL)

A small aperture extended depth of focus hydrophobic acrylic intraocular lens.

Intervention Type: DEVICE

Other Intervention Names

IC-8 IOL

Eligibility Criteria

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.

• Minimum Eligible Age: 22 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

AcuFocus, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Magda Michna, Ph.D.

Role: STUDY_DIRECTOR

AcuFocus, Inc.

Locations

Asian Eye Institute

Makati City, , Philippines

Singapore National Eye Centre (SNEC); Singapore Eye Research Institute (SERI)

Singapore, , Singapore

Countries

Philippines; Singapore

Other Identifiers

IC8-204-EXP2

Identifier Type: -

Identifier Source: org_study_id