Corrected VA With Long-Term Follow-Up After AcrySof® Intraocular Lens (IOL) Implantation

NCT02450799 | Completed Results

• 2 other identifiers: ILQ245-P001UMIN000017727
• Study Type: interventional
• Target: 104
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to compare the long-term visual acuity (VA) with an acrylic IOL to a silicone or polymethylmethacrylate (PMMA) IOL in cataract patients. This study will take place in Japan.

Conditions

Pseudophakia

Outcome Measures

Primary Outcomes (1)

• Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at the Long-Term, Post-Implantation Visit

  Measurement of best corrected (with spectacles or other visual corrective devices) visual acuity (at both near and distance). Visual Acuity (VA) is measured in logMAR (logarithm of the minimum angle of resolution). A lower logMAR value indicates better visual acuity. One eye (study eye) contributed to the analysis.

  Baseline (up to and including 3 months after implantation), long-term post-implantation visit (14-20 years after implantation)

Study Arms (3)

AcrySof IOL

EXPERIMENTAL

Acrylic IOL, prior implantation (1994-2000) in one or both eyes

Device: Acrylic IOL

Silicone IOL

ACTIVE COMPARATOR

Silicone IOL, prior implantation (1994-2000) in one or both eyes

Device: Silicone IOL

PMMA IOL

ACTIVE COMPARATOR

PMMA IOL, prior implantation (1994-2000) in one or both eyes

Device: PMMA IOL

Interventions

Acrylic IOL DEVICE

Acrylic IOL for long-term implantation in the cataract patient

Also known as: AcrySof® Model MA30BA, AcrySof® Model MA60BM

AcrySof IOL

Silicone IOL DEVICE

Silicone IOL for long-term implantation in the cataract patient

Silicone IOL

PMMA IOL DEVICE

Polymethylmethacrylate IOL for long-term implantation in the cataract patient

PMMA IOL

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Willing to provide voluntary consent and able to comprehend and sign the informed consent form;
• Pseudophakic patients implanted with an Acrylic (AcrySof®), PMMA or silicone IOL from 1994 to 2000;
• Clear intraocular media in study eye;
• Best-corrected visual acuity (decimal) within 3 months post-implantation of 0.8 (decimal VA chart) or more in study eye;
• No ocular or systemic condition which may affect visual acuity in study eye;

You may not qualify if:

• Complications that may impact visual acuity in study eye at the time of the prospective visit, such as glaucoma, diabetic retinitis, ocular inflammatory disease, retinal detachment, and others as specified in the protocol;
• Previous refractive surgery in study eye;
• Previous IOL exchange in study eye;

Sponsors & Collaborators

• Alcon, a Novartis Company: lead

MeSH Terms

Conditions

Pseudophakia

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Phase IV, Clinical and Regulatory Affairs, Alcon Japan
• Organization: Alcon, A Novartis Division

alcon.medinfo@alcon.com

1-888-451-3937

Study Officials

• Group Manager, Clinical Dev.

  Alcon Japan, Ltd.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: May 19, 2015
• First Posted: May 21, 2015
• Study Start: June 1, 2015
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: December 9, 2016
• Results First Posted: December 9, 2016

Record last verified: 2016-10