Ignite Creation Date:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2026-01-26 @ 1:24 AM
Study NCT ID:
NCT01480934
Status:
COMPLETED
Last Update Posted:
2011-11-29
First Post:
2011-11-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Posterior Capsule Opacification in Eyes With Diabetes Mellitus
Sponsor:
Iladevi Cataract and IOL Research Center
Organization:
Study Overview
Official Title:
A Prospective Evaluation of Posterior Capsule Opacification in Eyes With Diabetes Mellitus -A Case Control Study
Status:
COMPLETED
Status Verified Date:
2011-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DM & PCO
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 .
the digital images were analyzed for PCO .
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: