Overview

The Relationship Between Intraocular Pressure and Macular Edema in Patients With Diabetic Macular Edema

Status:
Unknown status
Trial end date:
2018-07-01
Target enrollment:
0
Participant gender:
All
Summary
The Investigators propose to examine the effect of lowering the intraocular pressure on macular edema in Participants diagnosed with diabetic macular edema. Our theory is based on the assumption that lower intraocular pressure means higher Ocular Perfusion pressure, which may cause an improvement in retinal perfusion and thus an improvement in retinal oxygenation and reduced edema
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Meir Medical Center
Collaborator:
Meir Hospital, Kfar Saba, Israel
Treatments:
Brimonidine Tartrate
Brimonidine Tartrate, Timolol Maleate Drug Combination
Ophthalmic Solutions
Timolol
Criteria
Inclusion Criteria:

- Participants with a diagnosis of diabetic macular edema over the age of 18 which are
eligible to sign an agreement to participate in the study

- Presence of DME (based on clinical examination of retinal specialist + OCT) in both
eyes with an edema thickness ranged from 350 to 800 microns

- Media lucid enough to allow sufficient quality photographs by OCT

Exclusion Criteria:

- Patients which do not have a valid diagnosis of DME (Diabetic Macular Edema)

- Patients with problems that can cause macular edema in any other:

- Age-Related Macular Degeneration

- Central retinal vein occlusion (CRVO)/Branch retinal vein occlusion (BRVO)
/central retinal artery occlusion (CRAO) / branch retinal artery occlusion (BRAO)

- Epiretinal membrane (ERM) or Vitreo-macular traction (VMT)

- Patients who are Pseudophakic in one eye or pseudophakic in both eyes for less
than a year

- Patients treated in order to reduce the DME by intra-vitreal injection or by
laser in the past six months

- Patients which are currently treat with Intra ocular Pressure lowering drops in
at least one eye, or have been treated in the past with laser of any kind or with
surgery

- Patients who underwent Pars plana vitrectomy one or both eyes

- Patients who cannot undergo an OCT examination

- Patients who want prefer to be treated by the current practices based on clinical
judgment

- Patients with a condition that requires an intervention or laser surgery during
the 3 months of study, such as active Proliferative diabetic retinopathy,
vitreous hemorrhage or other similar conditions