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

Cataract Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05574270
• Other study ID #: IC8-204-EXP2
• Status: Recruiting
• Phase: N/A
• Start date: July 12, 2022
• Est. completion date: January 12, 2024

Study information

• Verified date: December 2022
• Source: AcuFocus, Inc.
• Contact: Laura Schall
• Phone: 336-306-0587
• Email: lschall[@]acufocus.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: January 12, 2024
• Est. primary completion date: January 12, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 22 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Astigmatism
• Cataract
• Irregular Astigmatism
• Presbyopia

Intervention

Device:
• IC-8 Intraocular Lens (IOL)
A small aperture extended depth of focus hydrophobic acrylic intraocular lens.

Locations

Country	Name	City	State
Philippines	Asian Eye Institute	Makati City
Singapore	Singapore National Eye Centre (SNEC); Singapore Eye Research Institute (SERI)	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
AcuFocus, Inc.

Countries where clinical trial is conducted

Philippines,  Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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