NCT03633695

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 453 (actual)
• Sponsor: AcuFocus, Inc. · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed 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.

Conditions

• Cataract
• Presbyopia

Interventions

Type	Name	Description
DEVICE	IC-8 IOL Group	A monofocal IOL (TECNIS ZCB00, ZCT150 or ZCT225 or AcrySof IQ SA60WF, SA6AT3 or SA6AT4) implanted in the first eye for use over the lifetime of the patient. The IC-8 IOL implanted in the second eye for use over the lifetime of the patient.
DEVICE	Control Group	A monofocal IOL (TECNIS ZCB00, ZCT150 or ZCT225 or AcrySof IQ SA60WF, SA6AT3 or SA6AT4) bilaterally implanted for lifetime use of the patient.

Timeline

• Start date: 2018-12-04
• Primary completion: 2020-10-15
• Completion: 2020-10-15
• First posted: 2018-08-16
• Last updated: 2022-10-24
• Results posted: 2022-10-24

Locations

21 sites across 1 country: United States

Regulatory

• FDA-regulated device study