Evaluation of Posterior Capsule Opacification in Eyes With Diabetes Mellitus

NCT01480934 | Completed DMC

• 1 other identifier: 01072007
• Study Type: observational
• Target: 150
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Development of Posterior Capsule Opacification

Keywords

Diabetes,posterior capsule opacification,case control study

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• duration of diabetes, stage of diabetic retinopathy

  4 years

Study Arms (2)

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

(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

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

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients who underwent phacoemulsification for age-related cataract

You may qualify if:

• 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).

You may not qualify if:

• patients with glaucoma,
• high myopia (axial length \> 27.0 mm),
• pseudoexfoliation,
• traumatic cataract,
• subluxated cataract,
• previous ocular surgeries,
• allergy to dilating drops.

Sponsors & Collaborators

• Iladevi Cataract and IOL Research Center: lead

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Gauri D Shah, M.S

  Iladevi Cataract &IOL Research Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2011
• First Posted: November 29, 2011
• Study Start: June 1, 2005
• Primary Completion: January 1, 2010
• Study Completion: June 1, 2010
• Last Updated: November 29, 2011

Record last verified: 2011-11