Visual Outcomes After Cataract Surgery: Multifocal AcrySof® IQ ReSTOR® Intraocular Lenses Versus Monofocal Intraocular Lenses

Cataract Clinical Trial

Official title:

Visual Outcomes After Bilateral Surgical Cataract Phacoemulsification: AcrySof® ReSTOR IOL Implantation Compared to Monofocal IOL Implantation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01290068
• Other study ID #: RDG-10-269
• Status: Completed
• Phase: N/A
• Start date: April 2011
• Est. completion date: October 2012

Study information

• Verified date: March 2017
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess and compare visual outcomes of the AcrySof® IQ ReSTOR® +3.0 D intraocular lens (IOL) to a commercially available monofocal IOL in cataract patients.

Description:

This study included subjects with bilateral age-related cataracts and either no preoperative corneal astigmatism, or preoperative regular corneal astigmatism confirmed by autokeratometry of ≤2.5 D.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 208
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• Willing and able to understand and sign an Informed Consent;

• Willing and able to attend post-operative examinations as per protocol schedule;

• Diagnosis of bilateral, age-related cataracts;

• Planned cataract removal via phacoemulsification with implantation of an IOL;

• Available to undergo second eye surgery within 6 weeks of the first eye surgery;

• Fulfill the recommendations of the "Warnings" and "Precautions" sections of the AcrySof IQ ReSTOR IOL and Monofocal IOL package inserts;

• No preoperative corneal astigmatism or preoperative regular corneal astigmatism =2.5D;

• Qualify in both eyes for either AcrySof® IQ ReSTOR® IOL Model SN6AD1 or AcrySof® IQ ReSTOR® Toric IOL Models SND1T2 through SND1T5 as indicated by the AcrySof IQ ReSTOR Multifocal Toric web-based calculator;

• Able to read and understand one of the following languages: Dutch, French, German, Italian, Spanish, English or Catalan.

• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

• Previous corneal surgery and/or reshaping;

• Any abnormality, disease and/or conditions of the cornea (ie, keratoconus, corneal dystrophy, severe keratitis, corneal scar, etc.), which would clinically contraindicate the implantation of a toric IOL;

• Planned multiple procedures during cataract/IOL implantation surgery;

• Planned limbal relaxing incisions, excimer laser treatment or similar procedures prior to or during the course of the study;

• Pregnant, lactating, or planning pregnancy during the course of study;

• Other protocol-defined exclusion criteria may apply.

Related Conditions & MeSH terms

• Cataract

Intervention

Device:
• AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL
Multifocal IOL with extended secondary focal point implanted for long-term use over the lifetime of the cataract patient
• AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL
Multifocal IOL with extended secondary focal point and astigmatism correction implanted for long-term use over the lifetime of the cataract patient
• Monofocal IOL
Monofocal IOL implanted for long-term use over the lifetime of the cataract patient

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Classified as Responders	Distance VA and near VA were measured binocularly (both eyes together) without visual correction using ETDRS (Early Treatment of Diabetic Retinopathy Study) charts positioned at a consistent, manufactured distance. VA was measured in logMAR (logarithm of the minimum angle of resolution), with a lower logMAR value indicating better visual acuity. A responder was defined as a participant who achieved bilateral uncorrected distance visual acuity and bilateral uncorrected near visual acuity of =0.1 LogMAR at the Month 6 visit.	Month 6 after second eye implantation
Primary	Proportion of Participants Reporting Spectacle Independence at All Distances	Spectacle independence at all distances; ie, where type of spectacles used/prescribed equaled 'No spectacles', was evaluated. If for the 6-month visit, spectacle type information was missing for the spectacle independence endpoint, but the subject attended this 6-month visit, subject was assumed to be spectacle independent.	Month 6 after second eye implantation
Primary	Mean Vision-Related Quality of Life as Reported on the NEI-RQL 42 (5 Dimensions)	Vision-related quality of life dimensions were evaluated using the National Eye Institute Refractive Error Quality of Life instrument (NEI-RQL 42), a self-administered questionnaire. Each dimension was scored between 0 to 100, with a higher score indicating a better vision-related Quality of Life. 5 of the dimensions were prespecified as primary.	Month 6 after second eye implantation
Secondary	Median Total Spectacle Cost Prior to Any Reimbursement	Total spectacle cost includes the frame, lens, and any reimbursement from national health systems or private insurance. Costs collected in pounds sterling were converted to euros.	Month 6 after second eye implantation

External Links

•   Results from the Novartis Clinical Trial Results Website