Comparison of the Quality of Vision Provided by AMO Tecnis Z9000 and Alcon Laboratories MA60 Acrysof Posterior Chamber Intraocular Lenses

NCT00348270 | Completed Phase 4

• 1 other identifier: R367/25/2004
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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 chamber intraocular lens.

Conditions

Cataract

Keywords

Cataract; Intraocular lens; Aberration; Wavefront

Outcome Measures

Primary Outcomes (1)

• The primary outcome of this comparative study is the best corrected mesopic log contrast sensitivity function of eyes implanted with Z9000 and MA60 lenses at 6 cycles/degree, 90-120 days postoperatively.

Secondary Outcomes (5)

• The best corrected mesopic log contrast sensitivity function of eyes implanted with Z9000 and MA60 lenses at 1.5, 3, 12, and 18 cycles/degree, 90-120 days postoperatively

• The change in best corrected mesopic log contrast sensitivity function after cataract surgery (postoperatively minus preoperatively) at 1.5, 3, 6, 12, and 18 cycles/degree

• The residual spherical aberrations of the postoperative eye using wavefront analysis

• Logarithm of the minimum angle of resolution (LogMAR) visual acuity

• Postoperative ocular complications/adverse events

Interventions

Tecnis Z9000 intraocular lens DEVICE

MA60 intraocular lens DEVICE

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Singapore National Eye Centre: lead

Study Sites (1)

Singapore National Eye Centre

Singapore, 168751, Singapore

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Study Officials

• Wei-Han Chua

  Singapore National Eye Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: July 3, 2006
• First Posted: July 4, 2006
• Study Start: July 1, 2005
• Primary Completion: October 1, 2008
• Study Completion: October 1, 2008
• Last Updated: May 12, 2010

Record last verified: 2010-05

Locations

SG (1)