Wavefront Analisys and Contrast Sensitivity of Spherical... | NCT00347243

Studies
Wavefront Analisys and Contrast Sensitivity of Spherical and Aspherical Intraocular Lenses

NCT00347243

Sponsor

Federal University of São Paulo

Status

Completed

Last Update Posted

Oct 26, 2006Estimated

Enrollment

Not provided

Phase

Phase 4

Conditions

Cataract
Pseudophakia

Interventions

phacoemulsification (cataract surgery)

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

Mar 2006

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

Sep 2005

Primary Completion Date

Not provided

Completion Date

Jun 2006

First Submitted Date

Jun 30, 2006

First Submission Date that Met QC Criteria

Jun 30, 2006

First Posted Date

Jul 4, 2006Estimated

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

Oct 25, 2006

Last Update Posted Date

Oct 26, 2006Estimated

Description Module

Brief Summary

Purpose:To compare visual performance, total and high order wavefront aberrations (coma, spherical aberration and other terms) and contrast sensitivity in eyes implanted with one monofocal aspheric intraocular lens (IOL) and two spherical IOLs (SofPort AO, Soflex,AcrySof®IQ (40 eyes), AcrySof®Natural and AMO®Sensar)

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 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Name	Type	Description	Arm Group Labels	Other Names
phacoemulsification (cataract surgery)	Procedure

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with bilateral visually significant senile cataract, corneal astigmatism less than 2.0 diopters and potential acuity meter (PAM) better than 0.2 LogMar

Exclusion Criteria:

any other ocular diseases, such as corneal opacities or irregularity, dry eye, amblyopia, anisometropia, glaucoma, retinal abnormalities, surgical complications, IOL tilt, decentration (estimated by retro illumination and digital photo) greater than 0.4mm13 or loss of follow-up

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Paulo Schor, MD	UNIFESP - EPM	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Federal University of Sao paulo		São Paulo	São Paulo	04044-020	Brazil

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
15232477	Result	Altmann GE. Wavefront-customized intraocular lenses. Curr Opin Ophthalmol. 2004 Aug;15(4):358-64. doi: 10.1097/00055735-200408000-00013.

ID	Term
D007905	Lens Diseases
D005128	Eye Diseases
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D018918	Phacoemulsification
D002387	Cataract Extraction

ID	Term
D054140	Refractive Surgical Procedures
D013508	Ophthalmologic Surgical Procedures
D013514	Surgical Procedures, Operative
D059708	Ultrasonic Surgical Procedures

ID	Term
D002386	Cataract
D019591	Pseudophakia