NCT00855491

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2003

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2003

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2004

Completed
4.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 3, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 4, 2009

Completed
Last Updated

March 4, 2009

Status Verified

March 1, 2009

Enrollment Period

1.2 years

First QC Date

March 3, 2009

Last Update Submit

March 3, 2009

Conditions

Posterior Capsule Opacification

Keywords

PCOPOCO

Outcome Measures

Primary Outcomes (1)

  • the percentage area of PCO with posterior capsule opacity (POCO) software

    4 years

Secondary Outcomes (1)

  • the presence of PCO within the central 3-mm zone were noted

    4 years

Study Arms (2)

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

PhacoPROCEDURE

AcrySof Single-Piece IOL

Also known as: emmetropic eyes, normal axial length
1. MYOPIA2. Emmetropia

Eligibility Criteria

Age50 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Raghudeep Eye Clinic

Ahmedabad, Gujarat, 52, India

Location

Study Officials

  • ALPESH SHAH, MS

    Iladevi Cataract and IOL Research Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 3, 2009

First Posted

March 4, 2009

Study Start

July 1, 2003

Primary Completion

September 1, 2004

Study Completion

November 1, 2008

Last Updated

March 4, 2009

Record last verified: 2009-03

Locations

IN(1)