Phase 4
N=52
Contralateral ReSTOR / Monofocal or Phakic Eye
Cataracts
Bottom Line
View on ClinicalTrials.gov: NCT00731640 ↗Enrolled (actual)
52
Serious AEs
0.0%
Results posted
Mar 2010
Primary outcome: Primary: Visual Acuity — -0.04; -0.01; 0.14; 0.18 LogMar
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- ReSTOR (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Alcon Research
- Primary completion
- May 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Visual Acuity |
-0.04; -0.01; 0.14; 0.18; 0.04; 0.09 | — |
| SECONDARY Contrast Sensitivity |
1.95; 1.90; 1.85; 1.84; 1.82; 1.81 | — |
| SECONDARY Patient Satisfaction |
6.85; 7.63 | — |
| SECONDARY Spectacle Independence |
65; 56 | — |
Summary
Bilateral evaluation of unilateral implantation of ReSTOR and contralateral monofocal or phakic eye.
Eligibility Criteria
Inclusion Criteria
- Unilateral operable cataract
- Candidate for presbyopic intraocular lens (IOL)
Exclusion Criteria
- Ocular comorbidities compromising primary outcome
- Bilateral cataracts
Data sourced from ClinicalTrials.gov (NCT00731640). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.