Evaluation of Posterior Capsule Opacification in Eyes With Diabetes Mellitus

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01480934

Acronym

DM & PCO

Enrollment

150

Registered

2011-11-29

Start date

2005-06-30

Completion date

2010-06-30

Last updated

2011-11-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Development of Posterior Capsule Opacification

Keywords

Diabetes,posterior capsule opacification,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 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 .

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

50 Years to 75 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Outcome results