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

NCT05574270 | Completed

• 1 other identifier: IC8-204-EXP2
• Study Type: interventional
• Target: 45
• Locations: 2 countries
• Sites: 2

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.

Conditions

Cataract; Presbyopia; Irregular Astigmatism

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• Monocular and Binocular Contrast Sensitivity

  4-6 Months

Study Arms (1)

IC-8 IOL Group

EXPERIMENTAL

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)

Interventions

IC-8 Intraocular Lens (IOL) DEVICE

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

Also known as: IC-8 IOL

IC-8 IOL Group

Eligibility Criteria

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

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);
• 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).

You may not qualify if:

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

Sponsors & Collaborators

• AcuFocus, Inc.: lead

Study Sites (2)

Asian Eye Institute

Makati City, Philippines

Location

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

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: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2022
• First Posted: October 10, 2022
• Study Start: July 12, 2022
• Primary Completion: November 28, 2024
• Study Completion: November 28, 2024
• Last Updated: December 19, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

PH (1); SG (1)