Treatment of Post-surgical Cystoid Macular Edema With Topical Steroids Trial (TEMPEST-1)



Status:Active, not recruiting
Conditions:Cardiology, Ocular
Therapuetic Areas:Cardiology / Vascular Diseases, Ophthalmology
Healthy:No
Age Range:18 - Any
Updated:8/20/2016
Start Date:August 2012
End Date:December 2017

Use our guide to learn which trials are right for you!

The purpose of this study is to compare the change in visual acuity of patients with post
surgical cystoid macular edema who will be treated with two different regimens.

Compare the mean change in BCVA over 12 weeks of Prednisolone Acetate 1% q1h (every hour) WA
(While Awake) + Ketorolac 0.5% qid (four times a day) versus Prednisolone Acetate qid +
Ketorolac qid for post surgical cystoid macular edema.

Inclusion Criteria:

- Age more than or equal to 18 years

- Diagnosis of PSCME in study eye confirmed by FA showing leakage from retinal vessels
resulting in pooling of dye in the fovea and Spectralis SD-OCT showing intraretinal
fluid in or around the fovea.

- BCVA score in the study eye of 20/30 to 20/400 inclusive (Snellen equivalents using
the ETDRS protocol at a distance of 4 meters).

- In the opinion of the investigator, decreased vision in the study eye is due to
foveal thickening from PSCME and not to any other reason.

Exclusion Criteria:

- Any patient who has other retinal diseases known to cause macular edema (choroidal
neovascularization, vein occlusion, diabetic macular edema in the study eye).
Patients with nonexudative Age Related Macular Degeneration (ARMD) or
non-proliferative diabetic retinopathy without macular edema can be included in the
study.

- Other reason for decreased visual acuity (such as amblyopia, foveal atrophy, optic
atrophy).

- Pre-existing diagnosis of glaucoma in the study eye

- Inability to comply with study or follow up procedures

- Pregnancy (Women of child bearing age will be asked to take a urine pregnancy test
prior to enrolling in the study).
We found this trial at
1
site
Baltimore, Maryland
?
mi
from
Baltimore, MD
Click here to add this to my saved trials