UnknownNot Applicable

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

Israel25 participantsStarted 2017-03-26

Plain-language 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

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 o…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change of at least 50 micron in Macular edema

Timeframe: Baseline measurement will be conducted at the recruitment of the participant, the second measurement will be preformed after one moth from recruitment and the third and last measurement will be preformed after 3 months from recruitment

Trial details

NCT IDNCT02718547

SponsorMeir Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-03-30

Contact for this trial

Nimrod Dar, MD

+972545937757 nimrod.dar@gmail.com

View on ClinicalTrials.gov More Complications of Diabetes Mellitus trials