VisiOn Restoration With FluidVisION Accommodating Intraocular Lens (AIOL)

NCT03925545 | Completed FDA Device

• 1 other identifier: CTP07700
• Study Type: interventional
• Target: 85
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cataract

Outcome Measures

Primary Outcomes (3)

• Accommodative Amplitude (AA)

  Accommodative amplitude is the ability of the eye to change its focus from distant to near objects.

  Month 6 postoperative

• Distance Corrected Visual Acuity

  Visual acuity was measured with distance correction (plus or minus power) in place.

  Month 6 postoperative

• International Organization for Standardization (ISO)-defined Cumulative and Persistent Adverse Events for Posterior Chamber IOL

  Adverse events were categorized per ISO 11979-7: Ophthalmic Implants - Intraocular Lenses - Part 7: Clinical Investigations.

  Up to Month 6 postoperative

Secondary Outcomes (3)

• Accommodative Amplitude

  Month 3 postoperative

• Minimum Add Power Required to Achieve Best Corrected Near Visual Acuity

  Up to Month 6 postoperative

• Uncorrected Visual Acuity

  Up to Month 6 postoperative

Study Arms (2)

Unilateral

EXPERIMENTAL

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

Device: FluidVision AIOL; Procedure: Cataract surgery

Contralateral

EXPERIMENTAL

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

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

Interventions

FluidVision AIOL DEVICE

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

Contralateral; Unilateral

AcrySof IQ monofocal IOL DEVICE

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

Contralateral

Cataract surgery PROCEDURE

Standard cataract extraction with phacoemulsification

Contralateral; Unilateral

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• PowerVision: lead

MeSH Terms

Conditions

Cataract

Interventions

Cataract Extraction

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Refractive Surgical Procedures; Ophthalmologic Surgical Procedures; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2019
• First Posted: April 24, 2019
• Study Start: January 17, 2017
• Primary Completion: November 27, 2018
• Study Completion: November 27, 2018
• Last Updated: May 21, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share