Ignite Creation Date:
2024-05-05 @ 12:03 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00229931
Status:
COMPLETED
Last Update Posted:
2023-12-28
First Post:
2005-09-28
Brief Title:
Triamcinolone vs Laser for Diabetic Macular Edema
Sponsor:
University of Oklahoma
Organization:
University of Oklahoma
Study Overview
Official Title:
The Role of Triamcinolone Injection During Cataract Extraction for Diabetic Patients With Pre-Operative Macular Edema
Status:
COMPLETED
Status Verified Date:
2023-12
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:
IVTA
Brief Summary:
The purpose of this study is to determine if intravitreal triamcinolone acetonide IVTA injection at the time of cataract surgery will improve visual acuity and decrease post-operative swelling in diabetic patients requiring cataract extraction as compared to the conventional treatment of laser following cataract surgery
The subjects will be followed for 11 visits over 3 year Visits will occur at screening1 36912182430 and 36 months post surgery
The subjects will be followed for 11 visits over 3 year Visits will occur at screening1 36912182430 and 36 months post surgery
Detailed Description:
Protocol Summary
This is a randomized prospective study comparing diabetic patients with pre-operative macular edema undergoing cataract surgery treated with either 4 mg of intravitreal triamcinolone at the time of cataract surgery or focal laser treatment 1 month following cataract surgery
Disease State
The conventional treatment for clinically significant macular edema is focal laser photocoagulation In some diabetic patients however the cataract often impedes fundus visualization for optimal laser treatment In these patients focal laser treatment is deferred until after cataract surgery
Study aim
The purpose of this study is to determine if intravitreal triamcinolone acetonide IVTA injection at the time of cataract surgery will improve visual acuity and decrease post-operative macular edema in diabetic patients with pre-operative macular edema requiring cataract extraction as compared to the conventional treatment of focal laser photocoagulation following cataract surgery
Hypothesis
We propose that by injecting triamcinolone intravitreally at the time of cataract surgery in patients who have pre-operative macular edema we will not only reduce the risk of exacerbating macular edema but also possibly improve the final visual outcome
Study Procedures
After informed consent is obtained each patient will be placed based on a randomization scheme into either the control group receiving the conventional focal laser treatment one month following cataract extraction or into the study group receiving the IVTA injection at the time of surgery
This is a randomized prospective study comparing diabetic patients with pre-operative macular edema undergoing cataract surgery treated with either 4 mg of intravitreal triamcinolone at the time of cataract surgery or focal laser treatment 1 month following cataract surgery
Disease State
The conventional treatment for clinically significant macular edema is focal laser photocoagulation In some diabetic patients however the cataract often impedes fundus visualization for optimal laser treatment In these patients focal laser treatment is deferred until after cataract surgery
Study aim
The purpose of this study is to determine if intravitreal triamcinolone acetonide IVTA injection at the time of cataract surgery will improve visual acuity and decrease post-operative macular edema in diabetic patients with pre-operative macular edema requiring cataract extraction as compared to the conventional treatment of focal laser photocoagulation following cataract surgery
Hypothesis
We propose that by injecting triamcinolone intravitreally at the time of cataract surgery in patients who have pre-operative macular edema we will not only reduce the risk of exacerbating macular edema but also possibly improve the final visual outcome
Study Procedures
After informed consent is obtained each patient will be placed based on a randomization scheme into either the control group receiving the conventional focal laser treatment one month following cataract extraction or into the study group receiving the IVTA injection at the time of surgery
Study Oversight
Has Oversight DMC:
None
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?:
None