Micropulse LaserNCT07295704
Micropulse Laser in Treatment of Initial and Refractory Cases of Center-Involved Diabetic Macular Edema
An observational study of Micropulse Laser and Treatment, run by The General Authority for Teaching Hospitals and Institutes at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Micropulse Laser, Treatment, Initial
- What is being tested?
- Micropulse Laser
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Oct 2025to 30 Mar 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This prospective cohort comparative study was conducted at the Ophthalmology Department of Sohag Teaching Hospital, with approval from the institutional ethical committee.
Who may be able to join
- 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).
Who cannot join
- Monocular eyes.
- Chronic renal failure or renal transplant because of diabetic nephropathy.
- Glycated hemoglobin (HbA1c) of more than 10%.
- Vitreomacular traction syndrome.
- Epiretinal membrane.
- PRP within 4months before the treatment.
Show all 13Show fewer
- Intraocular surgery within 6months, including cataract or vitreoretinal operation.
- Rubeosis iridis.
- Severe glaucoma.
- High-risk proliferative diabetic retinopathy.
- Poor dilation.
- Increased foveal avascular zone.
- Any condition that could interfere with optical coherence tomography (OCT) measurement or visual acuity.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
the General Authority for Teaching Hospitals and Institutes
Cairo, 11562
Hossam A Hassan, MD, 00201026808348, Dr.hossameabdalfataah@gothi.gov.eg
About this study
Official title: Comparative Evaluation of Micropulse Laser in Treatment of Initial and Refractory Cases of Center-Involved Diabetic Macular Edema
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.
Read the detailed description
Diabetic Retinopathy (DR) is a common and specific microvascular complication of diabetes that affects 17-54% of people with diabetes aged between 49 and 60 years.
Diabetic macular edema (DME) is one of the most common causes of visual loss in today's society. It affects about 10% of diabetic individuals and 29% of those who have had the condition for more than 20 years.
In micropulse mode, the laser emits short pulses, thereby reducing thermal energy in the target area.
This strategy has two properties: a shorter exposure time and a subvisible clinical endpoint, delivering energy by dividing the beam into a series of short pulses (100-300 µs). Every single pulse has an "on and off" duration (duty cycle (DC)), enabling tissues to cool down before the next pulse.
- Being tested
- Micropulse Laser
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Micropulse LaserOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Naïve center-involved diabetic macular edema group | Patients with treatment-naïve center-involved diabetic macular edema. Receives: Other: Micropulse Laser | |
| Refractory center-involved diabetic macular edema group | Patients with refractory center-involved diabetic macular edema. Receives: Other: Micropulse Laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of best-corrected visual acuity
Change of best-corrected visual acuity will be recorded.
Measured: 6 months post-procedure
Secondary outcomes (3)
Change of central macular thickness
Change of central macular thickness will be recorded.
Measured: 6 months post-procedure
Change of area thickness
Change of area thickness will be recorded.
Measured: 6 months post-procedure
Change of macular volume
Change of macular volume will be recorded.
Measured: 6 months post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2025
- Study start15 Oct 2025
- Primary completion30 Mar 2026 (estimated)
- Study completion30 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Micropulse LaserStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The General Authority for Teaching Hospitals and Institutes
- Sponsor type
- Research network
- Responsible party
- Principal investigator, Hossam Abdelfattah Husein Hassan, The General Authority for Teaching Hospitals and Institutes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07295704
- Sponsor's protocol ID
- HSO00011
- Status last verified
- Dec 2025
- First submitted
- 6 Dec 2025
- Last updated
- 22 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of Micropulse Laser in Treatment of Initial and Refractory Cases of Center-Involved Diabetic Macular Edema
- ClinicalTrials.gov ID
- NCT07295704
- Acronym / sponsor ID
- HSO00011
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- The General Authority for Teaching Hospitals and InstitutesResearch network
- Study start
- 15 Oct 2025 (actual)
- Primary completion
- 30 Mar 2026 (estimated)
- Study completion
- 30 Mar 2026 (estimated)
- First posted
- 22 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Diabetic Retinopathy (DR) is a common and specific microvascular complication of diabetes that affects 17-54% of people with diabetes aged between 49 and 60 years.
Diabetic macular edema (DME) is one of the most common causes of visual loss in today's society. It affects about 10% of diabetic individuals and 29% of those who have had the condition for more than 20 years.
In micropulse mode, the laser emits short pulses, thereby reducing thermal energy in the target area.
This strategy has two properties: a shorter exposure time and a subvisible clinical endpoint, delivering energy by dividing the beam into a series of short pulses (100-300 µs). Every single pulse has an "on and off" duration (duty cycle (DC)), enabling tissues to cool down before the next pulse.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Naïve center-involved diabetic macular edema group | – | Other: Micropulse LaserPatients with treatment-naïve center-involved diabetic macular edema. |
| Refractory center-involved diabetic macular edema group | – | Other: Micropulse LaserPatients with refractory center-involved diabetic macular edema. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This prospective cohort comparative study was conducted at the Ophthalmology Department of Sohag Teaching Hospital, with approval from the institutional ethical committee.
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (13 listed)
- Monocular eyes.
- Chronic renal failure or renal transplant because of diabetic nephropathy.
- Glycated hemoglobin (HbA1c) of more than 10%.
- Vitreomacular traction syndrome.
- Epiretinal membrane.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Micropulse LaserAll 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. | Other | Naïve center-involved diabetic macular edema group, Refractory center-involved diabetic macular edema group |
Primary outcome
Change of best-corrected visual acuity
Time frame: 6 months post-procedure
Change of best-corrected visual acuity will be recorded.
3 secondary outcomes
Change of central macular thickness
Time frame: 6 months post-procedure
Change of area thickness
Time frame: 6 months post-procedure
Change of macular volume
Time frame: 6 months post-procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2025.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Micropulse Laser and Treatment, run by The General Authority for Teaching Hospitals and Institutes at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hossam A Hassan, MD (00201026808348, Dr.hossameabdalfataah@gothi.gov.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of best-corrected visual acuity (time frame: 6 months post-procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2025.