Evaluation of Posterior Capsule Opacification in Eyes With Diabetes Mellitus

Development of Posterior Capsule Opacification Clinical Trial

— DM & PCO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01480934
• Other study ID #: 01072007
• Status: Completed
• Phase: N/A
• First received: November 24, 2011
• Last updated: November 28, 2011
• Start date: June 2005
• Est. completion date: June 2010

Study information

• Verified date: November 2011
• Source: Iladevi Cataract and IOL Research Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: June 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years to 75 Years

Eligibility

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

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Capsule Opacification
• Development of Posterior Capsule Opacification
• Diabetes Mellitus

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Iladevi Cataract and IOL Research Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No