Evaluation of Posterior Capsule Opacification in Eyes With Diabetes Mellitus

Completed

• Conditions: Development of Posterior Capsule Opacification

• Registration Number: NCT01480934
• Lead Sponsor: Iladevi Cataract and IOL Research Center

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 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 Timeline

• Study Start: 2005-06
• Primary Completion: 2010-01
• Study Completion: 2010-06
• Status Verified: 2011-11
• Study First Submitted: 2011-11-24
• Study First Submitted QC: 2011-11-28
• Last Update Submitted: 2011-11-28
• Study First Posted: 2011-11-29
• Last Update Posted: 2011-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.