An interventional study of Subthreshold 532nm laser in Non Central Diabetic Macular Edema, sponsored by Marashi Eye Clinic. Completed at 1 site in Syrian Arab Republic. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2018-10-29.
Sponsored by Marashi Eye Clinic · Not applicable, Interventional, and Treatment
Is to determine if SDM laser can reduce macular thickness in non central CSME and stop the progression of non central CSME to central CSME in compare to glycemic control
interventional randomised masked study will recruit patients have diabetes mellitus with non central CSME with good vision into two groups : 1st SDM laser with glycemic control 2nd SHAM laser with Glycemic control where BCVA will be recorded every month starting from baseline to 24 weeks where OCT will be recorded every 8 weeks from baseline to 24 weeks
756 studies on the registry are indexed under Macular Edema; 65 are open to participants now.
This study's enrollment of 8 is below the median of 56 across 584 interventional studies indexed under Macular Edema.
Browse Macular Edema studies →Marashi Eye Clinic is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Applying 532nm subtherhold laser with 5% duty cycle using high density low intensity protocol at the area of non central clinical significant macular edema
Device: Subthreshold 532nm laser
Subthershold 532nm laser
Number of eyes with reduced macular thickness
Measurements of retinal thickness in the area of edema
Time frame: 24 weeks
Number of eyes with reduced vision
Best corrected visual acuity at the end of the study
Time frame: 24 weeks
Number of eyes developing central macular edema
Time frame: 24 weeks
Number of patients achieved good glycemic control
By measuring HbA1C every 12 weeks from baseline
Time frame: 24 weeks
Plan to share: No
Ran from Jul 2017 to primary completion in Jan 2018, 6 months.
Of 46 non-industry interventional studies with no phase under Macular Edema, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 42. This study's 6 months is below that.
Counting every sponsor, half of 50 studies reached it within 21 months; a quarter within 9 and three quarters within 37.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Marashi Eye Clinic