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

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.

Study Overview

• Status: Recruiting
• Conditions: Cataract; Presbyopia; Irregular Astigmatism
• Intervention / Treatment: Device: IC-8 Intraocular Lens (IOL)

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 Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Laura Schall; Phone Number: 336-306-0587; Email: lschall@acufocus.com

Study Locations

• Philippines
  • Makati City, Philippines
    • Recruiting
    • Asian Eye Institute
    • Contact: Robert Ang, M.D.; Phone Number: (02) 8-898-2020
• Singapore
  • Singapore, Singapore
    • Recruiting
    • Singapore National Eye Centre (SNEC); Singapore Eye Research Institute (SERI)
    • Contact: Jodhbir Mehta, MBBS, FRCOphth; Phone Number: (65) 6576 7200

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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. 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Device: IC-8 Intraocular Lens (IOL); A small aperture extended depth of focus hydrophobic acrylic intraocular lens.; Other Names: IC-8 IOL

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Monocular uncorrected distance visual acuity (UCDVA)	Mean acuity from the IC-8 IOL eye at 4-6 Months is statistically better compared to preoperative	4-6 Months
Monocular uncorrected intermediate visual acuity (UCIVA)	Mean acuity from the IC-8 IOL eye at 4-6 Months is statistically better compared to preoperative	4-6 Months
Monocular uncorrected near visual acuity (UCNVA)	Mean acuity from the IC-8 IOL eye at 4-6 Months is statistically better compared to preoperative	4-6 Months
Monocular best-corrected distance visual acuity (BCDVA) in the IC-8 IOL eye	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	4-6 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Monocular and Binocular Contrast Sensitivity	Photopic and Mesopic contrast sensitivity (with and without glare) in each eye and both eyes will be analyzed. No success criterion or hypothesis testing.	4-6 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): July 12, 2022
• Primary Completion (Anticipated): January 12, 2024
• Study Completion (Anticipated): January 12, 2024

Study Registration Dates

• First Submitted: October 7, 2022
• First Submitted That Met QC Criteria: October 7, 2022
• First Posted (Actual): October 10, 2022

Study Record Updates

• Last Update Posted (Estimate): December 7, 2022
• Last Update Submitted That Met QC Criteria: December 6, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Refractive Errors; Cataract; Presbyopia; Astigmatism
• Other Study ID Numbers: IC8-204-EXP2

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