Clinical Evaluation of a Small Aperture Extended Depth of Focus Intraocular Lens

AcuFocus

Status: Completed

Conditions: Cataract; Presbyopia

Treatments: Device: Control Group; Device: IC-8 IOL Group

Study type: Interventional

Funder types: Industry

Identifiers

NCT03633695

SAIL-101-UNI

Details and patient eligibility

About

The purpose of this study is to determine the safety and effectiveness of the IC-8 IOL implanted in one eye and a monofocal or monofocal toric IOL implanted in the fellow eye in accordance with the indication.

Full description

Eligible patients will complete up to 12 study visits over a 12-month period. All subjects will complete a preoperative examination of both eyes to assess study eligibility: operative visit (each eye) and up to 9 postoperative visits (Day 1 - each eye, Week 1 - each eye, Month 1 - each eye or combined, Month 3 - both eyes, Month 6 - both eyes, and Month 12 - both eyes). The first eye must meet specific qualification criteria in order to proceed with IOL implantation in the second eye. The second eye should be implanted within 45 days of the first eye.

Enrollment: 453 patients

Sex: All

Ages: 22+ years old

Volunteers: Accepts Healthy Volunteers

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 visits;
4. Planned crystalline lens removal by phacoemulsification, with or without femtosecond laser-assisted extraction, and posterior chamber IOL implantation in both eyes;
5. Cataractous lens changes as demonstrated by best-corrected visual acuity (BCDVA) of 20/40 or worse either with or without a glare source present;
6. Potential for postoperative BCDVA of 20/25 or better in each eye
7. Clear intraocular media, other than cataract.

Exclusion criteria

1. Requiring an IC-8 intraocular lens outside the available spherical power range
2. Pharmacologically dilated pupil size less than 6 mm in either eye;
3. Inability to achieve stable keratometric readings for contact lens wearers
4. Irregular astigmatism in either eye;
5. Preoperative corneal astigmatism > 1.50 diopters in either eye
6. Active or recurrent anterior segment pathology
7. Presence of ocular abnormalities other than cataract as specified in the protocol
8. Diagnosis of dry eye in which patients are unable to maintain eye comfort or adequate vision even with dry eye medication;
9. Congenital cataracts;
10. Previous corneal or intraocular surgery
11. History of ocular trauma or ocular conditions expected to require retinal laser treatment or other surgical intervention;
12. Systemic conditions as specified in the protocol;
13. Patient is pregnant, plans to become pregnant, or is lactating
14. Concurrent participation or participation in any clinical trial up to 30 days prior to preoperative visit.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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453 participants in 2 patient groups

IC-8 IOL Group

Experimental group

Description:

A monofocal IOL (TECNIS ZCB00, ZCT150 or ZCT225 or AcrySof IQ SA60WF, SA6AT3 or SA6AT4) implanted in the first eye. The AcuFocus IC-8 IOL implanted in the second eye.

Treatment:

Device: IC-8 IOL Group

Control Group

Active Comparator group

Description:

A monofocal IOL (TECNIS ZCB00, ZCT150 or ZCT225 or AcrySof IQ SA60WF, SA6AT3 or SA6AT4) bilaterally implanted.

Treatment:

Device: Control Group