Subthreshold Diode LaserNCT07591662
Subthreshold Diode Laser Versus Trabeculotomy in Treatment of Advanced Primary Open Angle Glaucoma
A study testing Subthreshold diode laser and Trabeculotomy in people with Subthreshold Diode Laser and Trabeculotomy, run by Kafrelsheikh University at 1 site in Egypt.
Trial summary
This study aimed to compare between subthreshold diode laser and trabeculotomy in treatment of advanced primary open angle glaucoma throughout 12 months follow-up. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Subthreshold Diode Laser, Trabeculotomy, Advanced Primary Open Angle Glaucoma
- What is being tested?
- Subthreshold diode laser and Trabeculotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2024to 1 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
Who may be able to join
- Patients older than 18 years.
- Open angle glaucoma.
- Advanced glaucoma (visual field deterioration MD>-12.00 dB with evidence of optic neuropathy despite maximal therapy).
Who cannot join
- Previous intraocular surgery for glaucoma.
- Patients who had undergone previous laser therapy for glaucoma.
- Cases of secondary glaucoma.
- Media opacity interferes with capturing fundus image.
Trial locations and contacts
1 site in 1 country.
About this study
This study aimed to compare between subthreshold diode laser and trabeculotomy in treatment of advanced primary open angle glaucoma throughout 12 months follow-up.
Read the detailed description
Glaucoma is a common eye disease that can cause irreversible blindness if left undiagnosed and untreated. Glaucoma is caused by elevated intraocular pressure (IOP) that leads to optic nerve damage and visual field loss.
Trabeculectomy operation was first described more than 50 years ago and is considered the most commonly performed surgery worldwide for glaucoma patients.
Subthreshold transscleral cyclophotocoagulation is a micropulse delivery mode of diode laser that has been used recently to treat glaucoma by ablating the ciliary processes and reducing the aqueous humour production.
- Conditions
- Subthreshold Diode Laser, Trabeculotomy, Advanced Primary Open Angle Glaucoma, Intraocular Pressure
- Being tested
- Subthreshold diode laser, Trabeculotomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subthreshold diode laserProcedure or surgery
Patients scheduled for subthreshold diode laser.
TrabeculotomyProcedure or surgery
Patients scheduled for trabeculotomy.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Patients scheduled for subthreshold diode laser. Receives: Procedure: Subthreshold diode laser |
| Group B | Experimental | Patients scheduled for trabeculotomy. Receives: Procedure: Trabeculotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual acuity
Visual acuity was evaluated using finger counting, hand motion, or light perception
Measured: 12 months postoperatively
Secondary outcomes (2)
Intraocular pressure
Intraocular pressure was measured and success criteria included an IOP ranging from 6 to 21 mmHg or a minimum 20% decline from baseline, with or without antiglaucoma drugs.
Measured: 12 months postoperatively
Degree of pain
Postoperative pain was assessed using a visual analogue scale from 0 to 10 cm: 0-4 cm for mild, 5-7 cm for moderate, and 8-10 cm for intense pain.
Measured: 12 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2026
- Study start1 Jun 2024
- Primary completion1 Dec 2024
- Study completion1 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subthreshold Diode LaserStudies of the same condition, open and under way.
- More trials run by Kafrelsheikh UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kafrelsheikh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Mahmoud Refaat Elahmady, Kafrelsheikh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07591662
- Sponsor's protocol ID
- MD.22.12.724
- Status last verified
- May 2026
- First submitted
- 9 May 2026
- Last updated
- 18 May 2026
- 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 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Subthreshold Diode Laser Versus Trabeculotomy in Treatment of Advanced Primary Open Angle Glaucoma
- ClinicalTrials.gov ID
- NCT07591662
- Acronym / sponsor ID
- MD.22.12.724
- Conditions
- Subthreshold Diode Laser, Trabeculotomy, Advanced Primary Open Angle Glaucoma, Intraocular Pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Kafrelsheikh UniversityUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 18 May 2026 (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 aimed to compare between subthreshold diode laser and trabeculotomy in treatment of advanced primary open angle glaucoma throughout 12 months follow-up.
Detailed description
Glaucoma is a common eye disease that can cause irreversible blindness if left undiagnosed and untreated. Glaucoma is caused by elevated intraocular pressure (IOP) that leads to optic nerve damage and visual field loss.
Trabeculectomy operation was first described more than 50 years ago and is considered the most commonly performed surgery worldwide for glaucoma patients.
Subthreshold transscleral cyclophotocoagulation is a micropulse delivery mode of diode laser that has been used recently to treat glaucoma by ablating the ciliary processes and reducing the aqueous humour production.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Procedure: Subthreshold diode laserPatients scheduled for subthreshold diode laser. |
| Group B | Experimental | Procedure: TrabeculotomyPatients scheduled for trabeculotomy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients older than 18 years.
- Open angle glaucoma.
- Advanced glaucoma (visual field deterioration MD>-12.00 dB with evidence of optic neuropathy despite maximal therapy).
Key exclusion criteria (4 listed)
- Previous intraocular surgery for glaucoma.
- Patients who had undergone previous laser therapy for glaucoma.
- Cases of secondary glaucoma.
- Media opacity interferes with capturing fundus image.
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 |
|---|---|---|
| Subthreshold diode laserPatients scheduled for subthreshold diode laser. | Procedure or surgery | Group A |
| TrabeculotomyPatients scheduled for trabeculotomy. | Procedure or surgery | Group B |
Primary outcome
Visual acuity
Time frame: 12 months postoperatively
Visual acuity was evaluated using finger counting, hand motion, or light perception
2 secondary outcomes
Intraocular pressure
Time frame: 12 months postoperatively
Degree of pain
Time frame: 12 months postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2026.
- 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.
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Subthreshold diode laser and Trabeculotomy in people with Subthreshold Diode Laser and Trabeculotomy, run by Kafrelsheikh University 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 3 inclusion and 4 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: finished, as of the sponsor's last update on 18 May 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual acuity (time frame: 12 months postoperatively). 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 18 May 2026.