Micropulse Laser in Treatment of Initial and Refractory Cases of Center-Involved Diabetic Macular Edema

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorThe General Authority for Teaching Hospitals and Institutes

About this trial

This study aims to evaluate the effect of subthreshold 577 nm micropulse laser photocoagulation in the treatment of initial and refractory cases of Center-Involved Diabetic Macular Edema.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥18 years.

Both sexes.

Patients with type 1 or 2 diabetes mellitus (DM), best-corrected visual acuity (BCVA) of 20/400 or better, and center-involved DME [defined as a central macular thickness (CMT) of >250 but <700µm measured by spectral-domain optical coherence tomography].

Patients with any level of non-proliferative diabetic retinopathy or proliferative diabetic retinopathy with adequate panretinal photocoagulation (PRP) and no signs of disease activity determined by fluorescein angiography (FA).

Disqualifiers

Monocular eyes.

Chronic renal failure or renal transplant because of diabetic nephropathy.

Glycated hemoglobin (HbA1c) of more than 10%.

Vitreomacular traction syndrome.

Trial population

This prospective cohort comparative study was conducted at the Ophthalmology Department of Sohag Teaching Hospital, with approval from the institutional ethical committee.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Micropulse Laser

    Other intervention

    All laser procedures will be performed in a darkened room. The laser will be delivered together in an 8×8 pattern mode with high density (0µm of spacing) over the entire area of macular edema, including the foveal center and unthickened (200µm) retina with no attempt to target or avoid microaneurysms.

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Naïve center-involved diabetic macular edema group1 intervention
Group B: Refractory center-involved diabetic macular edema group1 intervention

Trial outcomes

Primary outcomes

1

Change of best-corrected visual acuity

Change of best-corrected visual acuity will be recorded.

Time frame
6 months post-procedure

Secondary outcomes

1

Change of central macular thickness

Change of central macular thickness will be recorded.

Time frame
6 months post-procedure
2

Change of area thickness

Change of area thickness will be recorded.

Time frame
6 months post-procedure
3

Change of macular volume

Change of macular volume will be recorded.

Time frame
6 months post-procedure

Other outcomes

Sponsors and contacts

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