Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00229918
Status:
UNKNOWN
Last Update Posted:
2005-09-30
First Post:
2005-09-28
Brief Title:
PSTLaser v Laser Alone for CSME
Sponsor:
Edward Hines Jr VA Hospital
Organization:
Edward Hines Jr VA Hospital
Study Overview
Official Title:
Combined Posterior Sub-Tenon Injection of Triamcinolone Acetonide and Laser Photocoagulation for the Treatment of Clinically Significant Macular Edema
Status:
UNKNOWN
Status Verified Date:
2005-09
Last Known Status:
RECRUITING
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:
None
Brief Summary:
Prospective randomized clinical trial comparing Laser Alone v Laser and posterior sub-tenon injection of triamcinolone acetonide for primary and refractory clinically significant macular edema
Detailed Description:
Clinically significant macular edema CSME is one of the leading causes of vision loss in diabetic retinopathy The current standard of care for CSME is focalgrid laser photocoagulation However many patients experience further vision loss andor require multiple laser treatments In recent studies intraocular intravitreal injection of triamcinolone acetonide has been shown to be beneficial for CSME however risks of this procedure include endophthalmitis and increased risk of steroid-induced intraocular pressure IOP elevation Posterior sub-Tenon injection PST of triamcinolone acetonide is commonly used for inflammatory conditions of the eye and recently has been increasingly used for diabetic macular edema The objective of this study is to determine whether combined treatment with PST triamcinolone acetonide and laser photocoagulation for CSME has decreased rates of moderate vision loss increased visual gain and decrease in central macular thickness compared to laser photocoagulation alone Both primary no previous history of focalgrid laser and refractory previous history of focalgrid laser CMSE will be studied Thirty 30 eyes with primary CSME and thirty 30 eyes with refractory CSME will be randomized into one of two groups 1 PSTLaser group and 2 Laser alone group All patients will have an Optical Coherence Tomography OCT at the initial and final visits Patients assigned to PSTLaser group will use topical steroid 1 prednisolone acetate four times a day for two weeks Patients who have elevated IOP with topical steroids will not receive PST steroid injection Following treatments patients will be evaluated at 1 and 2 months for a dilated eye exam visual acuity and assessment of IOP Moderate vision loss loss of 15 ETDRS letters vision gain in ETDRS letters and central macular thickness measured by OCT will be compared between groups Multivariate analysis will also be used to compare outcomes from the two arms of the study
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