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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Iladevi Cataract and IOL Research Center
ClinicalTrials.gov Identifier:
NCT01480934
First received: November 24, 2011
Last updated: November 28, 2011
Last verified: November 2011
History of Changes
  Purpose

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
Development of Posterior Capsule Opacification

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

MedlinePlus related topics: Cataract Diabetes
U.S. FDA Resources

Further study details as provided by Iladevi Cataract and IOL Research Center:

Primary Outcome Measures:
  • Development of Posterior capsule opacification. [ Time Frame: 4 years ] [ Designated as safety issue: No ]
    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:
  • duration of diabetes, stage of diabetic retinopathy [ Time Frame: 4 years ] [ Designated as safety issue: No ]
    The stage of diabetic retinopathy and duration of diabetes was correlated with the degree of PCO in the cases group.


Enrollment: 150
Study Start Date: June 2005
Study Completion Date: June 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
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).

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 .

  Eligibility

Ages Eligible for Study:   50 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

patients who underwent phacoemulsification for age-related cataract

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01480934

Sponsors and Collaborators
Iladevi Cataract and IOL Research Center
Investigators
Principal Investigator: Gauri D Shah, M.S Iladevi Cataract &IOL Research Centre
  More Information

No publications provided

Responsible Party: Iladevi Cataract and IOL Research Center
ClinicalTrials.gov Identifier: NCT01480934     History of Changes
Other Study ID Numbers: 01072007
Study First Received: November 24, 2011
Last Updated: November 28, 2011
Health Authority: India: Institutional Review Board

Keywords provided by Iladevi Cataract and IOL Research Center:
Diabetes,posterior capsule opacification,case control study

Additional relevant MeSH terms:
Diabetes Mellitus
Capsule Opacification
Glucose Metabolism Disorders
Metabolic Diseases
 Endocrine System Diseases
Cataract
Lens Diseases
Eye Diseases

ClinicalTrials.gov processed this record on May 16, 2013