Presbyopia-Correcting Intraocular Lenses (IOLs)
This study has been completed.
Sponsor:
Alcon Research
Information provided by:
Alcon Research
ClinicalTrials.gov Identifier:
NCT00963560
First received: August 19, 2009
Last updated: July 13, 2011
Last verified: July 2011
- Full Text View
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Purpose
The purpose of this study is to prospectively evaluate postoperative visual and refractive parameters in a series of subjects bilaterally implanted with Presbyopia-Correcting Intraocular Lenses (IOLs).
| Condition | Intervention | Phase |
|---|---|---|
|
Cataract |
Device: ReSTOR +3 Device: Crystalens HD Device: Crystalens AO |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Single Group Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| Official Title: | A Randomized, Subject-masked Comparison of Visual Function After Bilateral Implantation of Presbyopia-correcting IOLs |
Resource links provided by NLM:
Further study details as provided by Alcon Research:
Primary Outcome Measures:
- Best Corrected Visual Acuity [ Time Frame: 6 Months after surgery ] [ Designated as safety issue: No ]Best corrected vision was tested at 4 meters (m), 60 centimeters (cm), 40cm and at preferred distance (distance chosen by each subject) with a standard ETDRS chart for distance and a hand held chart for near. Scores were calculated using logMAR values. LogMAR is the "logarithm of the minimum angle of resolution". A lower logMAR value indicates better visual acuity. Preferred distance for each study group was as follows: ReSTOR +3 = 38.7 +/- 6.8 cm, Crystalens HD = 49.9 +/- 9.8 cm, Crystalens AO = 53.1 +/- 9.8 cm.
| Enrollment: | 132 |
| Study Start Date: | August 2009 |
| Primary Completion Date: | March 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: ReSTOR +3
Bilateral implantation of ReSTOR +3 Intraocular Lens (IOL)
|
Device: ReSTOR +3
Bilateral implantation of the AcrySof ReSTOR Aspheric +3 Model SN6AD1 Intraocular lens (IOL) for the treatment of cataract.
|
|
Active Comparator: Crystalens HD
Bilateral implantation of Crystalens HD Intraocular Lens (IOL)
|
Device: Crystalens HD
Bilateral implantation of the Crystalens HD intraocular lens (IOL) for the treatment of cataract.
|
|
Active Comparator: Crystalens AO
Bilateral implantation of Crystalens AO Intraocular Lens (IOL)
|
Device: Crystalens AO
Bilateral implantation of the Crystalens AO intraocular lens (IOL) for the treatment of cataract.
|
Eligibility| Ages Eligible for Study: | 21 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- diagnosed with bilateral cataracts
- candidate for presbyopic lens
Exclusion Criteria:
- > 1 Diopter preoperative astigmatism by Keratometry readings
- pre-existing conditions that could skew the results
Contacts and Locations More Information
No publications provided
| Responsible Party: | Diane Houtman, Director - Global Scientific Market Affairs Dept, Alcon Laboratories, Inc. |
| ClinicalTrials.gov Identifier: | NCT00963560 History of Changes |
| Other Study ID Numbers: | M09-008 |
| Study First Received: | August 19, 2009 |
| Results First Received: | July 13, 2011 |
| Last Updated: | July 13, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Alcon Research:
|
ReSTOR +3 |
Additional relevant MeSH terms:
|
Presbyopia Cataract Refractive Errors Eye Diseases Lens Diseases |
ClinicalTrials.gov processed this record on May 23, 2013