A Prospective Evaluation of Posterior Capsule Opacification in Eyes With Diabetes Mellitus -A Case Control Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 150
- Primary Endpoint
- Development of Posterior capsule opacification.
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 .
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 50 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Outcomes
Primary Outcomes
Development of Posterior capsule opacification.
Time Frame: 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 Outcomes
- duration of diabetes, stage of diabetic retinopathy(4 years)