Status:
COMPLETED
Comparison of the Quality of Vision Provided by AMO Tecnis Z9000 and Alcon Laboratories MA60 Acrysof Posterior Chamber Intraocular Lenses
Lead Sponsor:
Singapore National Eye Centre
Conditions:
Cataract
Eligibility:
All Genders
50-80 years
Phase:
PHASE4
Brief Summary
This study is a comparison of the quality of vision provided by AMO Tecnis Z9000 three-piece silicone posterior chamber intraocular lens and Alcon Laboratories MA60 three-piece acrylic posterior chamb...
Detailed Description
Today, intraocular lenses (IOLs) are routinely implanted after cataract extraction. Cataract surgical techniques are constantly developing due to innovations in surgical implantation and IOL manufactu...
Eligibility Criteria
Inclusion
- Bilateral cataracts, eligible for phacoemulsification with primary implantation of a posterior chamber IOL
- Males and females 50 to 80 years of age
- Expected maximum of 6-weeks and minimum of 3 weeks interval between a single patient's surgeries
- Best corrected visual acuity (BCVA) should be no better than 20/40 in the presence of a glare source. (In the early treatment diabetic retinopathy study \[ETDRS\] visual acuity chart, better than 20/40 will be at least 3 letters read correctly in the 20/30 line).
- Best corrected visual acuity projected by Potential Acuity Meter (PAM) or other reliable potential acuity test procedure to be 20/30 or better in each eye after cataract removal and IOL implantation.
- Naturally dilated pupil size (in dim light) ≥ 4.0 mm (with no dilation medications) - both eyes
- Anticipated correction with an IOL of +6 to +30 diopters (both eyes)
- Evidence of a personally signed and dated informed consent document indicating the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the trial
- Willing and able to comply with scheduled visits and other study procedures
Exclusion
- Preoperative pathology: amblyopia, rubella cataract, proliferative diabetic retinopathy, shallow anterior chamber, macular edema, retinal detachment, aniridia or iris atrophy, uveitis, history of iritis, iris neovascularization, medically uncontrolled glaucoma, microphthalmus or macrophthalmus, optic nerve atrophy
- Previous intraocular or corneal surgery, including refractive surgery, corneal transplant
- Other pathologies potentially affecting visual acuity, e.g., macular degeneration, glaucoma with the presence of visual field defects
- An increased risk for complications which could require vitreoretinal surgery
- Corneal irregularities potentially affecting visual acuity, e.g., keratoconus, corneal dystrophy
- Corneal opacities
- Keratometric astigmatism exceeding 1.5 diopters
- Patient in whom postoperative refractive error is planned to be different between fellow eyes (anisometropia) such as in cases where postoperative refraction is planned for mono-vision
- Current contact lens usage (within 6 months prior to first surgery and/or during the study)
- Other ocular surgery at time of cataract extraction
- Uncontrolled diabetes
- Any neurological condition that might interfere with performance of required tests
- Immune deficiency disease
- Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study device implantation or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study
- Use of any systemic or topical drug known to interfere with visual performance
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2008
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00348270
Start Date
July 1 2005
End Date
October 1 2008
Last Update
May 12 2010
Active Locations (1)
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1
Singapore National Eye Centre
Singapore, Singapore, 168751