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DM & PCO: Evaluation of Posterior Capsule Opacification in Eyes With Diabetes Mellitus

Sponsor
Iladevi Cataract and IOL Research Center (Other)
Overall Status
Completed
CT.gov ID
NCT01480934
Collaborator
(none)
150
Enrollment
60
Duration (Months)

Study Details

Study Description

Brief Summary

To compare the development of posterior capsule opacification (PCO) between eyes with and without a history of diabetes mellitus (DM) after single-piece hydrophobic acrylic intraocular lens (IOL) implantation 4 years postoperatively.Diabetes mellitus would not increase the incidence of PCO at 4 years.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    There is a paucity of available literature that prospectively evaluates the development of PCO with the single-piece hydrophobic acrylic IOL implantation in diabetic versus non-diabetic eyes on a long-term basis. Therefore, this study was designed to compare the degree of PCO after cataract surgery between diabetic and age-matched non-diabetic patients. This prospective, observational case control study comprised patients who underwent phacoemulsification .The patients were asked to return for postoperative follow-up visits at 1 month, 1 year and 4 years.

    the digital images were analyzed for PCO .

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    150 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    A Prospective Evaluation of Posterior Capsule Opacification in Eyes With Diabetes Mellitus -A Case Control Study
    Study Start Date :
    Jun 1, 2005
    Actual Primary Completion Date :
    Jan 1, 2010
    Actual Study Completion Date :
    Jun 1, 2010

    Arms and Interventions

    Arm Intervention/Treatment
    Group:A-cases-Patients with a history of Diabetes Mellitus

    (N=75 eyes). The inclusion criteria for group A: Diabetes mellitus was defined as glycosylated haemoglobin (Hb A1c ) levels of 6% or more , use of diabetic medication (oral hypoglycemic agents, insulin injection or diet restriction), or a physician's diagnosis of diabetes.
    Group - B:controls

    Patients with uncomplicated age-related cataract who were otherwise healthy constituted the controls(Group:)B (n=75 eyes).

    Outcome Measures

    Primary Outcome Measures

    1. Development of Posterior capsule opacification. [4 years]

      This prospective, observational case control study comprised patients who underwent phacoemulsification .Subjects with a history of diabetes mellitus (DM) were designated as cases (n=75 eyes).Inclusion criteria for cases: Diabetes mellitus was defined as glycosylated haemoglobin (Hb A1c ) levels of 6% or more , use of diabetic medication (oral hypoglycemic agents, insulin injection or diet restriction), or a physician's diagnosis of diabetes. Patients with uncomplicated age-related cataract who were otherwise healthy constituted the controls (n=75 eyes).

    Secondary Outcome Measures

    1. duration of diabetes, stage of diabetic retinopathy [4 years]

      The stage of diabetic retinopathy and duration of diabetes was correlated with the degree of PCO in the cases group.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Diabetes mellitus was defined as glycosylated haemoglobin (Hb A1c ) levels of 6% or more ,

    • use of diabetic medication (oral hypoglycemic agents, insulin injection or diet restriction), or a physician's diagnosis of diabetes.

    • Patients with uncomplicated age-related cataract who were otherwise healthy constituted the controls (n=75 eyes).

    Exclusion Criteria:

    • patients with glaucoma,

    • high myopia (axial length > 27.0 mm),

    • pseudoexfoliation,

    • traumatic cataract,

    • subluxated cataract,

    • previous ocular surgeries,

    • allergy to dilating drops.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Iladevi Cataract and IOL Research Center

    Investigators

    • Principal Investigator: Gauri D Shah, M.S, Iladevi Cataract &IOL Research Centre

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Iladevi Cataract and IOL Research Center
    ClinicalTrials.gov Identifier:
    NCT01480934
    Other Study ID Numbers:
    • 01072007
    First Posted:
    Nov 29, 2011
    Last Update Posted:
    Nov 29, 2011
    Last Verified:
    Nov 1, 2011
    Keywords provided by Iladevi Cataract and IOL Research Center
    Diabetes,posterior capsule opacification,case control study
    Additional relevant MeSH terms:
    Capsule Opacification
    Diabetes Mellitus

    Study Results

    No Results Posted as of Nov 29, 2011