Evaluation of Posterior Capsule Opacification in Eyes With Diabetes Mellitus

Study Overview
=================
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 .

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

Conditions
-----------------
Development of Posterior Capsule Opacification

Participation Criteria
=================
Eligibility 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.

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group:A-cases-Patients with a history of Diabetes Mellitus<br>(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<br>Patients with uncomplicated age-related cataract who were otherwise healthy constituted the controls(Group:)B (n=75 eyes). | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Development of Posterior capsule opacification. | 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). | 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| duration of diabetes, stage of diabetic retinopathy | The stage of diabetic retinopathy and duration of diabetes was correlated with the degree of PCO in the cases group. | 4 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetes,posterior capsule opacification,case control study