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

Pseudophakia Clinical Trial

Official title:

Corrected VA With Long-Term Follow-Up After AcrySof® IOL Implantation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02450799
• Other study ID #: ILQ245-P001
• Secondary ID: UMIN000017727
• Status: Completed
• Phase: N/A
• First received: May 19, 2015
• Last updated: May 23, 2016
• Start date: June 2015
• Est. completion date: May 2016

Study information

• Verified date: May 2016
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• 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;

• Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

• 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;

• Other protocol-specified exclusion criteria may apply.

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor)

Related Conditions & MeSH terms

• Pseudophakia

Intervention

Device:
• AcrySof IOL
Acrylic IOL for long-term implantation in the cataract patient
• Silicone/PMMA IOL
Silicone or PMMA IOL for long-term implantation in the cataract patient

Locations

Country	Name	City	State
Japan	Contact Alcon Japan, Ltd. for Trial Locations	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Best Corrected Visual Acuity (BCVA) at the Long-Term, Post-Implantation Visit	VA will be assessed with subject's best spectacle correction or other visual corrective device in place. VA will be measured in decimal, with 1.0 decimal corresponding to 20/20 Snellen. A higher numeric value represents better visual acuity. One eye (study eye) will contribute to the analysis.	Baseline (up to and including 3 months after implantation), long-term post-implantation visit (14-20 years after implantation)	No