Wavefront Analyzes and Visual Performance of Three Multif... | NCT00876707

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

NCT00876707

Sponsor

University of Sao Paulo

Status

Completed

Last Update Posted

Jul 2, 2010Estimated

Enrollment

60Estimated

Phase

Phase 1Phase 2

Conditions

Cataract
Astigmatism

Interventions

Tecnis implant
ReSTOR implant
ReZoom implant

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2009

Primary Completion Date

Nov 2009Actual

Completion Date

Nov 2009Actual

First Submitted Date

Apr 3, 2009

First Submission Date that Met QC Criteria

Apr 6, 2009

First Posted Date

Apr 7, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 1, 2010

Last Update Posted Date

Jul 2, 2010Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
Tecnis	Active Comparator	Device: Tecnis implant
ReSTOR	Active Comparator	Device: ReSTOR implant
ReZoom	Active Comparator	Device: ReZoom implant

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Tecnis implant	Device	Implant of diffractive multifocal IOL Tecnis	Tecnis

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
visual acuity, wavefront data and modulation transfer function		30, 90 and 120 days after surgery

Secondary Outcomes

Measure	Description	Time Frame
contrast sensitivity		90 days after surgery

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of São Paulo		São Paulo	São Paulo	05403-000	Brazil

Condition Browse Module

MeSH Terms

ID	Term
D002386	Cataract
D001251	Astigmatism

Ancestor Terms

ID	Term
D007905	Lens Diseases
D005128	Eye Diseases
D012030	Refractive Errors

Browse Leaves

Not provided

Browse Branches

Not provided