NCT00348270

CompletedPhase 4

Comparison of the Quality of Vision Provided by AMO Tecnis Z...

Singapore National Eye Centre Source

Compare

Other study identifiers

Sponsor study identifier

R367/25/2004

Study Type

interventional

Estimated enrollment

80

Locations

1 country

Sites

1

Timeline

Study Start

July 2005

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

October 2008

Actual (reported)

Study Completion

October 2008

Actual (reported)

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Estimated enrollment: 80 participants
Study completion date: October 2008
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
July 2005
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
July 3, 2006
Actual (reported)
First Posted
July 4, 2006
Actual (reported)
Primary Completion
October 2008
Actual (reported)
Study Completion
October 2008
Actual (reported)

Last Updated: May 12, 2010
Status Verified: May 2010
Last Update Submitted: May 11, 2010

Conditions

Cataract

Keywords

CataractIntraocular lensAberrationWavefront

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 lensDevice

MA60 intraocular lensDevice

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age50 Years - 80 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (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

Sponsors & Collaborators

Singapore National Eye Centre
Governmentlead

Study Sites (1)

Singapore National Eye Centre

Singapore, 168751, Singapore

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens DiseasesEye 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 2005

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

October 2008

Actual (reported)

NCT01210807

Clinical Evaluation of the One-Piece Tecnis Multifocal Intraocular Lens (IOL)

Phase 4Completed

NCT00760058

Visual Outcome and Visual Quality After Bilateral Implantation of the AcrySof® IQ IOL Compared to MI60® and Tecnis® IOL

Phase 4Withdrawn

NCT00721253

Visual Outcomes of Subjects Bilaterally Implanted With ReSTOR Aspheric +4 vs. Tecnis or Acri.LISA

Phase 4Completed

NCT00449267

Aurolab Hydrophobic Foldable Intraocular Lens Study

Phase 4Completed

NCT00719732

Visual Function After Implantation of Bilateral AcrySof ReSTOR Aspheric +3

Phase 4Completed

NCT00312299

Posterior Capsule Opacification Study

Phase 4Completed

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

Contact the study team to confirm eligibility.

Study Completion

October 2008

Actual (reported)

Last Updated

May 12, 2010

Record last verified: 2010-05

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT00348270
Data provider: ClinicalTrials.gov
Source updated: 2010-05-12
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:29:15 UTC

Locations

SG(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations