A study to find out how well a gentle laser treatment lowers eye pressure in people with glaucoma whose eye drops are no longer working
| ISRCTN | ISRCTN62227730 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN62227730 |
| Sponsor | Special Hospital for Ophthalmology "Clinic Maja", Niš, Serbia |
| Funder | Special Hospital for Ophthalmology "Clinic Maja", Niš, Serbia |
- Submission date
- 09/04/2026
- Registration date
- 20/04/2026
- Last edited
- 20/04/2026
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Eye Diseases
Plain English summary of protocol
Background and study aims
Glaucoma is a long term eye condition that can damage the optic nerve and lead to irreversible sight loss. This damage is usually linked to high pressure inside the eye. Eye drops are the most common treatment, but for some people they do not lower the pressure enough. This study looked at a laser treatment called micropulse transscleral cyclophotocoagulation, or MP-TSCPC. The main aim was to find out how safe and how effective this treatment is over 6 months in people with two common types of glaucoma, primary open-angle glaucoma and pseudoexfoliative glaucoma. The study also aimed to see whether the results were similar for both types of glaucoma.
Who can participate?
Adults aged between 18 years and 85 years with primary open-angle glaucoma or pseudoexfoliative glaucoma could take part. All participants had eye pressure that remained above their target level despite using the maximum eye drop treatment they could tolerate. People who had previous glaucoma surgery, other types of glaucoma, active eye inflammation, or who could not give informed consent were not included.
What does the study involve?
Participants received a single MP-TSCPC laser treatment to help lower pressure inside the eye. The procedure was done using local anaesthetic around the eye. After treatment, participants continued their usual glaucoma eye drops. They attended follow-up visits over a period of 6 months. At these visits, eye pressure, vision, number of eye drops, and any side effects were recorded.
What are the possible benefits and risks of participating?
The possible benefit of taking part was a reduction in eye pressure, which may help slow further loss of vision. The treatment may also reduce the need for more invasive glaucoma surgery. MP-TSCPC is designed to be gentler than older laser treatments. In this study, no serious complications were reported. As with any eye procedure, potential risks include temporary discomfort, inflammation, or short term changes in vision.
Where is the study run from?
Special Hospital for Ophthalmology “Clinic Maja” in Niš, Serbia.
When is the study starting and how long is it expected to run for?
October 2018 to April 2022.
Who is funding the study?
Special Hospital for Ophthalmology “Clinic Maja” in Niš, Serbia.
Who is the main contact?
Professor Maja Zivkovic, drzivkovicmaja@gmail.com
Contact information
Principal investigator, Scientific, Public
Ophthalmology Clinic, University Clinical Center Niš
Nis
18000
Serbia
 ORCID ID |
0000-0002-4145-5242 |
|---|---|
| Phone | +381 668051551 |
| maja.zivkovic@medfak.ni.ac.rs |
Study information
| Primary study design | Interventional |
|---|---|
| Allocation | Non-randomized controlled trial |
| Masking | Open (masking not used) |
| Control | Uncontrolled |
| Assignment | Parallel |
| Purpose | Treatment |
| Scientific title | Outcomes of micropulse transscleral cyclophotocoagulation in primary open-angle and pseudoexfoliative glaucoma |
| Study objectives | To evaluate the 6-month efficacy and safety of micropulse transscleral cyclophotocoagulation (MP-TSCPC) in patients with medically refractory primary open-angle glaucoma and pseudoexfoliative glaucoma, and to compare treatment outcomes between the two glaucoma subtypes. |
| Ethics approval(s) |
Approved 25/09/2018, Ethics Committee of the Special Hospital for Ophthalmology "Clinic Maja" (Vizantijski Bulevar 33, Niš, 18000, Serbia; +381 18 533 036; info@klinikamaja.rs), ref: 09/9-2018-1 |
| Health condition(s) or problem(s) studied | Primary open-angle glaucoma, pseudoexfoliative glaucoma |
| Intervention | Micropulse transscleral cyclophotocoagulation (MP-TSCPC) using the Cyclo G6 system with MicroPulse P3 probe (Iridex Corporation) delivered at 2.0–2.2 W power, 31.3% duty cycle, for 90 seconds per hemisphere, under retrobulbar anesthesia. All patients continued their prescribed topical antiglaucoma medications postoperatively. Follow up for 180 days. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure(s) |
|
| Key secondary outcome measure(s) | |
| Completion date | 25/04/2022 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 85 Years |
| Sex | All |
| Target sample size at registration | 58 |
| Total final enrolment | 58 |
| Key inclusion criteria | 1. Patients with primary open-angle glaucoma (POAG) or pseudoexfoliative glaucoma (PEX) refractory to maximally tolerated topical medical therapy 2. Intraocular pressure above target despite maximum tolerated medical treatment 3. Scheduled for micropulse transscleral cyclophotocoagulation (MP-TSCPC) as the primary laser-surgical intervention |
| Key exclusion criteria | 1. Prior glaucoma surgery or laser treatment 2. Secondary glaucoma of other aetiology 3. Active ocular inflammation 4. Inability to provide informed consent |
| Date of first enrolment | 05/10/2018 |
| Date of final enrolment | 25/10/2021 |
Locations
Countries of recruitment
- Serbia
Study participating centres
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not expected to be made available |
| IPD sharing plan |
Editorial Notes
20/04/2026: Trial's existence confirmed by the Ethics Committee of the Special Hospital for Ophthalmology “Clinic Maja”
