Clinical Trial: Evaluation of Posterior Capsule Opacification in Eyes With Diabetes Mellitus

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: A Prospective Evaluation of Posterior Capsule Opacification in Eyes With Diabetes Mellitus -A Case Control Study

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.

Detailed Summary:

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 .


Sponsor: Iladevi Cataract and IOL Research Center

Current Primary Outcome: Development of Posterior capsule opacification. [ Time Frame: 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).


Original Primary Outcome: Same as current

Current Secondary Outcome: duration of diabetes, stage of diabetic retinopathy [ Time Frame: 4 years ]

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


Original Secondary Outcome: Same as current

Information By: Iladevi Cataract and IOL Research Center

Dates:
Date Received: November 24, 2011
Date Started: June 2005
Date Completion:
Last Updated: November 28, 2011
Last Verified: November 2011