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

Iladevi Cataract and IOL Research Center

Status: Completed

Conditions: Development of Posterior Capsule Opacification

Study type: Observational

Funder types: Other

Identifiers

NCT01480934

01072007

Details and patient eligibility

About

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.

Full 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 .

Enrollment: 150 patients

Sex: All

Ages: 50 to 75 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

150 participants in 2 patient groups

Group:A-cases-Patients with a history of Diabetes Mellitus

Description:

(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

Description:

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