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

Sponsor
Iladevi Cataract and IOL Research Center (Other)
Overall Status
Completed
CT.gov ID
NCT00855491
Collaborator
(none)
100
Enrollment
1
Location
2
Arms
64.1
Duration (Months)
1.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Procedure: Phaco
 N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
100 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Prospective Evaluation of Posterior Capsule Opacification in Myopic Eyes 4 Years After AcrySof Single-Piece IOL Implantation
Study Start Date :
Jul 1, 2003
Actual Primary Completion Date :
Sep 1, 2004
Actual Study Completion Date :
Nov 1, 2008

Arms and Interventions

Arm Intervention/Treatment
Experimental: 1. MYOPIA

axial length > 26.00 mm

Procedure: Phaco
AcrySof Single-Piece IOL
Other Names:
  • emmetropic eyes
  • normal axial length

    		•
    Active Comparator: 2. Emmetropia

    emmetropic eyes- eyes with an axial length of 21.00 to 23.99 mm

    Procedure: Phaco
    AcrySof Single-Piece IOL
    Other Names:
  • emmetropic eyes
  • normal axial length

    		•

    Outcome Measures

    Primary Outcome Measures

    1. the percentage area of PCO with posterior capsule opacity (POCO) software [4 years]

    Secondary Outcome Measures

    1. the presence of PCO within the central 3-mm zone were noted [4 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Raghudeep Eye Clinic Ahmedabad gUJARAT India 52

    Sponsors and Collaborators

    • Iladevi Cataract and IOL Research Center

    Investigators

    • Principal Investigator: ALPESH SHAH, MS, Iladevi Cataract and IOL Research Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00855491
    Other Study ID Numbers:
    • 03-009
    First Posted:
    Mar 4, 2009
    Last Update Posted:
    Mar 4, 2009
    Last Verified:
    Mar 1, 2009
    Keywords provided by , ,
    PCO
    POCO
    Additional relevant MeSH terms:
    Capsule Opacification

    Study Results

    No Results Posted as of Mar 4, 2009