VisiOn Restoration With FluidVisION Accommodating Intraocular Lens (AIOL)

NCT ID: NCT03925545

Last Updated: 2021-05-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 85 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-17
• Study Completion Date: 2018-11-27

Brief Summary

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.

Detailed 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.

Conditions

Cataract

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: SINGLE

Study Groups

Unilateral

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

Group Type: EXPERIMENTAL

FluidVision AIOL

Intervention Type: DEVICE

Investigational implantable medical device intended for long-term use over the lifetime of the cataract subject

Cataract surgery

Intervention Type: PROCEDURE

Standard cataract extraction with phacoemulsification

Contralateral

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

Group Type: EXPERIMENTAL

FluidVision AIOL

Intervention Type: DEVICE

Investigational implantable medical device intended for long-term use over the lifetime of the cataract subject

AcrySof IQ monofocal IOL

Intervention Type: DEVICE

Commercially available implantable medical device intended for long-term use over the lifetime of the cataract subject

Cataract surgery

Intervention Type: PROCEDURE

Standard cataract extraction with phacoemulsification

Interventions

FluidVision AIOL

Investigational implantable medical device intended for long-term use over the lifetime of the cataract subject

Intervention Type: DEVICE

AcrySof IQ monofocal IOL

Commercially available implantable medical device intended for long-term use over the lifetime of the cataract subject

Intervention Type: DEVICE

Cataract surgery

Standard cataract extraction with phacoemulsification

Intervention Type: PROCEDURE

Eligibility Criteria

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.

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.

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

PowerVision

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

CTP07700

Identifier Type: -

Identifier Source: org_study_id