VisiOn Restoration With FluidVisION Accommodating Intraocular Lens (AIOL) (ORION)

PowerVision

Status: Completed

Conditions: Cataract

Treatments: Device: FluidVision AIOL; Procedure: Cataract surgery; Device: AcrySof IQ monofocal IOL

Study type: Interventional

Funder types: Industry

Identifiers

NCT03925545

CTP07700

Details and patient eligibility

About

The objective of this study is to obtain an initial assessment of the safety and performance of an investigational AIOL in patients undergoing cataract extraction and IOL implantation.

Full description

This study was originally designed as a single arm, unilateral study (one eye, one product only) to obtain an initial assessment of the safety and performance of an investigational IOL in subjects undergoing cataract extraction and IOL implantation. The study design was later modified to a contralateral study (both eyes, different product in each eye) to compare the safety and performance of the investigational IOL to a commercially available monofocal IOL.

Enrollment: 85 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Corrected distance visual acuity (CDVA) worse than 20/40, or presence of visually significant lens opacity;
• Preoperative or predicted postoperative astigmatism of ≤ 1.0 diopter (D);
• Calculated IOL power within range.

Key Exclusion Criteria:

• Current medication that may affect accommodation;
• Systemic disease or concomitant medication that may increase operative risk or confound results;
• Ocular conditions that may predispose the subject for future complications;
• Monocular subjects or subjects with significant permanent visual function loss in fellow eye;
• Previous intraocular or corneal surgery in either eye that may confound the results or increase the risk to the subject, including implantation of a multifocal IOL or other presbyopic corrective surgery in the fellow eye;
• Grade 4 cataract of any type.

Trial design

Primary purpose: Device Feasibility

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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85 participants in 2 patient groups

Unilateral

Experimental group

Description:

Implantation with the FluidVision AIOL in one eye during cataract surgery. Only one eye was treated.

Treatment:

Procedure: Cataract surgery

Device: FluidVision AIOL

Contralateral

Experimental group

Description:

Implantation with the FluidVision AIOL in the first eye during cataract surgery, followed by implantation with the AcrySof IQ monofocal IOL in the fellow eye during a subsequent cataract surgery

Treatment:

Procedure: Cataract surgery

Device: FluidVision AIOL

Device: AcrySof IQ monofocal IOL