Posterior Capsule Opacification (PCO) With AcrySof Single... | NCT00855491

Studies
Posterior Capsule Opacification (PCO) With AcrySof Single-Piece IOL

NCT00855491

Sponsor

Iladevi Cataract and IOL Research Center

Status

Completed

Last Update Posted

Mar 4, 2009Estimated

Enrollment

100Actual

Phase

Not Applicable

Conditions

Posterior Capsule Opacification

Interventions

Phaco

Countries

India

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 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

Jul 2003

Primary Completion Date

Sep 2004Actual

Completion Date

Nov 2008Actual

First Submitted Date

Mar 3, 2009

First Submission Date that Met QC Criteria

Mar 3, 2009

First Posted Date

Mar 4, 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

Mar 3, 2009

Last Update Posted Date

Mar 4, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study what to evaluate if axial myopia might influence the development of PCO.

Detailed Description

We sought to prospectively compare PCO in eyes with myopia in relation to axial length with PCO in eyes with normal axial length, to decipher the role of axial myopia in PCO 4 years after surgery for senile cataract.

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1. MYOPIA	Experimental	axial length > 26.00 mm	Procedure: Phaco
2. Emmetropia	Active Comparator	emmetropic eyes- eyes with an axial length of 21.00 to 23.99 mm	Procedure: Phaco

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Phaco	Procedure	AcrySof Single-Piece IOL	1. MYOPIA 2. Emmetropia

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
the percentage area of PCO with posterior capsule opacity (POCO) software		4 years

Secondary Outcomes

Measure	Description	Time Frame
the presence of PCO within the central 3-mm zone were noted		4 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

local residency and presence of a cataract in an otherwise normal eye.
Patients older than 50 years
a dilated pupil after mydriasis
Patients with retinochoroidal atrophy, retinal laser prophylaxis,
hypertension

Exclusion Criteria:

nondilating pupil after maximal dilation;
pseudoexfoliation; mature, traumatic, black, or complicated cataracts;
previous intraocular surgery;
previous surgery for glaucoma;
uveitis
diabetes mellitus
Patients who did not give consent preoperatively

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 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

Name	Affiliation	Role
ALPESH SHAH, MS	Iladevi Cataract and IOL Research Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Raghudeep Eye Clinic		Ahmedabad	Gujarat	52	India