IOL: Wavefront Analyzes and Visual Performance of Three Multifocal Intra-ocular Lenses

• Sponsor: University of Sao Paulo (Other)
• Overall Status: Completed
• CT.gov ID: NCT00876707
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 3
• Duration (Months): 8
• Patients Per Site Per Month: 7.5

Study Details

Study Description

Brief Summary

The purpose of this study is to determine if differences in the design of multifocal intra-ocular lenses would mean different values of higher-order aberrations and different performance in objective parameters such as modulation transfer function.

Condition or Disease	Intervention/Treatment	Phase
Cataract; Astigmatism	Device: Tecnis implant; Device: ReSTOR implant; Device: ReZoom implant	Phase 1/Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Treatment
• Official Title: Phase 1 Study of Ocular Aberrations and Visual Performance of Eyes Implanted With Three Multifocal Intra-ocular Lenses
• Study Start Date: Mar 1, 2009
• Actual Primary Completion Date: Nov 1, 2009
• Actual Study Completion Date: Nov 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Tecnis	Device: Tecnis implant; Implant of diffractive multifocal IOL Tecnis
Active Comparator: ReSTOR	Device: ReSTOR implant; Implant of multifocal IOL ReSTOR
Active Comparator: ReZoom	Device: ReZoom implant; Implant of multifocal IOL ReZoom

Outcome Measures

Primary Outcome Measures

1. visual acuity, wavefront data and modulation transfer function [30, 90 and 120 days after surgery]

Secondary Outcome Measures

1. contrast sensitivity [90 days after surgery]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients with bilateral visually significant cataract with corneal astigmatism lower than 1.0D

Exclusion Criteria:

• Any ocular diseases, such as:

• corneal opacities or irregularity

• dry eye

• amblyopia

• anisometropia

• glaucoma

• retinal abnormality

• Surgical complications

• IOL tilt

• IOL decentration greater than 0.4 mm (estimated by retroillumination)

• Incomplete follow-up

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of São Paulo	São Paulo		Brazil	05403-000

Sponsors and Collaborators

• University of Sao Paulo

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00876707
• Other Study ID Numbers: 0088/09
• First Posted: Apr 7, 2009
• Last Update Posted: Jul 2, 2010
• Last Verified: Apr 1, 2009

• Keywords provided by , ,: wavefront; multifocal IOL; modulation transfer function; intraocular lenses; wavefront data; Visual performance
• Additional relevant MeSH terms: Cataract; Astigmatism

Study Results

No Results Posted as of Jul 2, 2010