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Glaucoma, Open AngleNCT07152132

SCTSC Versus Trabeculectomy in Medically Uncontrolled Open-Angle Glaucoma in Pseudophakic Patients

A study testing Trabeculectomy and Slow coagulation trans-scleral cyclophotocoagulation in people with Glaucoma, Open Angle, run by Minia University at 1 site in Egypt.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

cyclodiode versus trabeculectomy with MMC in pseudophakic patients. Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
Glaucoma, Open Angle
What is being tested?
Trabeculectomy and Slow coagulation trans-scleral cyclophotocoagulation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteEgypt
Study dates
20 Jul 2025to 30 Dec 2026
Phase
Interventional
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 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 1. Patients above 40 years old.
  • 2. POAG who underwent previous uncomplicated cataract surgery with intraocular lens implantation.
  • 3. Pseudophakic patients with medically uncontrolled glaucoma in spite of the use of two anti-glaucoma medications or intolerance to medical therapy.
  • 4. Visual field defects in both the superior and inferior hemi-fields outside the central 5 degrees of fixation.
  • 5. Mean deviation on perimetry ranges between -6 dB and -12 dB

Who cannot join

  • 1. Patients with history of previous glaucoma surgery. 2. Patients who have used topical steroids within the last three months. 3. Patients with significant media opacity, such as corneal opacity, that obstructs fundoscopic examination.
  • 4. Patients with ocular diseases as uveitis. 5. Patients with severe ocular surface disorders as ocular cicatricial pemphigoid.
  • 6. Aphakic patients. 7. Ocular interventions apart from YAG posterior capsulotomy.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Hazem M Abdelaziz, Master contact

01010045499

hazem.m.abdelaziz@mu.edu.eg

Mohamed Tarek M Abdelkader, MD contact

01028218703

Egypt1 site, 1 recruiting
  • Minia University Hospital

    Minya, 61111

    Hazem M Abdelaziz, 01117782048, hazem.m.abdelaziz@mu.edu.eg

    Recruiting

Other trials in Egypt

About this study

Official title: Slow Coagulation Trans-Scleral Cyclophotocoagulation Versus Trabeculectomy in Medically Uncontrolled Open-Angle Glaucoma in Pseudophakic Patients

cyclodiode versus trabeculectomy with MMC in pseudophakic patients.

Read the detailed description

Glaucoma is an optic neuropathy that is characterized by progressive structural and functional neuropathy. It is a leading cause of irreversible blindness.

Open angle glaucoma (OAG) is the commonest subtype of glaucoma. The number of patients diagnosed with POAG was estimated 52.68 million in 2020 and expected to be 79.76 million in 2040.

The management of OAG in patients with pseudophakia aims to IOP, which is the major modifiable risk factor for glaucoma progression. This can be achieved by medical, laser or surgical methods.

In many cases medical therapy can provide an effective IOP control, while surgery and laser are still indicated when the medical treatment fails to lower IOP sufficiently, or if the patient is not compliant with treatment.

Trabeculectomy with mitomycin C (MMC) is a filtration procedure that reduces IOP by creating a connection between the anterior chamber and the sub-conjunctival space after excision of a part of the trabecular meshwork. Pseudophakic eyes with OAG have a higher risk for surgical failure of trabeculectomy with MMC than the phakic eyes. Also it is associated with a higher incidence of complications as hypotony, lost anterior chamber or supra-choroidal effusion.

Laser therapy, as a cyclodestructive procedure, lowers IOP by reducing aqueous humor production. This is achieved through the application of diode laser energy to the sclera, which is absorbed by the melanin pigment in the ciliary processes, resulting in coagulative necrosis of the ciliary body. Historically, this treatment was regarded as a last-resort option for eyes with very limited visual potential due to the significant risks of uncontrolled inflammation and phthisis bulbi.

Now, with recent advances in laser probes and laser settings, the safety of trans-scleral cyclo-destruction has improved, rendering it a viable non-invasive option for a broader spectrum of patients including those with good visual acuity (VA) and as a primary procedure in management of OAG with pseudophakia.

Two approaches are commonly used to deliver laser energy using continuous wave trans-scleral cyclo-photocoagulation (CW-TSCPC): the conventional "pop" technique, where laser energy is initially increased until an audible, explosive, cavitating tissue-derived "pop" is heard. The laser power is then reduced until these pops are no longer audible. This method typically begins with a laser energy setting of approximately 1750-2000 mW, applied for a short duration of 2 seconds, and the treatment is delivered circumferentially along the limbus. In contrast, slow coagulation (SC) CW-TSCPC utilizes a lower amount of diode laser energy over an extended period, approximately 1250 mW over 4 seconds.

Previous results comparing the outcomes of the slow coagulation approach with the conventional high-energy pop approach found a lower incidence of postoperative complications in the slow coagulation group and comparable IOP- lowering effects between both groups. Although conventional CPC may have previously been reserved for blind painful eyes or eyes which have already failed prior glaucoma surgery, recent literature supports slow coagulation TSCPC (SC-TSCPC) as a reasonable primary option to lower IOP in eyes without prior incisional glaucoma surgery.

There have been few reports of SC-TSCPC being used as a primary surgical treatment in patients with glaucoma, and few studies published in the literature documenting the effect of SC-TSCPC in patients with good VA.

Being tested
Trabeculectomy, Slow coagulation trans-scleral cyclophotocoagulation
Keywords
SC-TSCPC, Trabeculectomy, OAG, Pseudophakic
Medical subject headings
Glaucoma, Open-Angle

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TrabeculectomyProcedure or surgery

    Trabeculectomy with mitomycin c application

  • Slow coagulation trans-scleral cyclophotocoagulationProcedure or surgery

    Slow coagulation trans-scleral cyclophotocoagulation

Study groups in NCT07152132
Study groupRoleWhat they receive
25 patients will undergo trabeculectomy with MMC (group B).Active comparator25 patients will undergo trabeculectomy with MMC (group B).
Receives: Procedure: Trabeculectomy
25 patients will be subjected to SC-TSCPC (group A)Active comparator25 patients will be subjected to SC-TSCPC (group A)
Receives: Procedure: Slow coagulation trans-scleral cyclophotocoagulation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. evaluate and compare the amount of iop reduction between SC-TSCPC and trabeculectomy with MMC in the management of medically uncontrolled OAG in pseudophakic eyes.

    measuring the IOP with Goldman applanation tonometer.

    Measured: 6 months

  2. evaluate and compare the degree of safety of SC-TSCPC versus trabeculectomy with MMC in the management of medically uncontrolled OAG in pseudophakic eyes.

    if there is any inflammatory reaction, lost anterior chamber , cystoid macular edema

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Sep 2025
  2. Study start20 Jul 2025
  3. Primary completion30 Sep 2026 (estimated)
  4. Study completion30 Dec 2026 (estimated)

Resources

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07152132
Sponsor's protocol ID
SC-TSCPC, Trabeculectomy
Other IDs
SC-TSCPC versus Trabeculectomy
Status last verified
Sep 2025
First submitted
7 Aug 2025
Last updated
25 Sep 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Kramp K, Vick HP, Guthoff R. Transscleral diode laser contact cyclophotocoagulation in the treatment of different glaucomas, also as primary surgery. Graefes Arch Clin Exp Ophthalmol. 2002 Sep;240(9):698-703. doi: 10.1007/s00417-002-0508-5. Epub 2002 Aug 1.

    PubMed 12271364
  • Egbert PR, Fiadoyor S, Budenz DL, Dadzie P, Byrd S. Diode laser transscleral cyclophotocoagulation as a primary surgical treatment for primary open-angle glaucoma. Arch Ophthalmol. 2001 Mar;119(3):345-50. doi: 10.1001/archopht.119.3.345.

    PubMed 11231767
  • Quigley HA. The Need for Rigor in Evaluating Micropulse and Other New Procedures. Ophthalmol Glaucoma. 2020 May-Jun;3(3):171-173. doi: 10.1016/j.ogla.2020.04.004. No abstract available.

    PubMed 32672611
  • Sheheitli H, Persad PJ, Feuer WJ, Sayed MS, Lee RK. Treatment Outcomes of Primary Transscleral Cyclophotocoagulation. Ophthalmol Glaucoma. 2021 Sep-Oct;4(5):472-481. doi: 10.1016/j.ogla.2020.12.014. Epub 2021 Jan 8.

    PubMed 33429109
  • Khodeiry MM, Liu X, Lee RK. Clinical outcomes of slow-coagulation continuous-wave transscleral cyclophotocoagulation laser for treatment of glaucoma. Curr Opin Ophthalmol. 2022 May 1;33(3):237-242. doi: 10.1097/ICU.0000000000000837. Epub 2022 Feb 23.

    PubMed 35200163
  • Duerr ER, Sayed MS, Moster S, Holley T, Peiyao J, Vanner EA, Lee RK. Transscleral Diode Laser Cyclophotocoagulation: A Comparison of Slow Coagulation and Standard Coagulation Techniques. Ophthalmol Glaucoma. 2018 Sep-Oct;1(2):115-122. doi: 10.1016/j.ogla.2018.08.007. Epub 2018 Aug 25.

    PubMed 32632402
  • Moussa K, Feinstein M, Pekmezci M, Lee JH, Bloomer M, Oldenburg C, Sun Z, Lee RK, Ying GS, Han Y. Histologic Changes Following Continuous Wave and Micropulse Transscleral Cyclophotocoagulation: A Randomized Comparative Study. Transl Vis Sci Technol. 2020 Apr 28;9(5):22. doi: 10.1167/tvst.9.5.22. eCollection 2020 Apr.

    PubMed 32821494
  • Conlon R, Saheb H, Ahmed II. Glaucoma treatment trends: a review. Can J Ophthalmol. 2017 Feb;52(1):114-124. doi: 10.1016/j.jcjo.2016.07.013. Epub 2016 Nov 17.

    PubMed 28237137
  • Oh LJ, Wong E, Lam J, Clement CI. Comparison of bleb morphology between trabeculectomy and deep sclerectomy using a clinical grading scale and anterior segment optical coherence tomography. Clin Exp Ophthalmol. 2017 Sep;45(7):701-707. doi: 10.1111/ceo.12953. Epub 2017 May 9.

    PubMed 28371125
  • Takihara Y, Inatani M, Seto T, Iwao K, Iwao M, Inoue T, Kasaoka N, Murakami A, Futa R, Tanihara H. Trabeculectomy with mitomycin for open-angle glaucoma in phakic vs pseudophakic eyes after phacoemulsification. Arch Ophthalmol. 2011 Feb;129(2):152-7. doi: 10.1001/archophthalmol.2010.348.

    PubMed 21320958
  • Correia Barbosa R, Goncalves R, Bastos R, Alves Pereira S, Basto R, Viana AR, Tenedorio P. Trabeculectomy Vs Non-penetrating Deep Sclerectomy for the Surgical Treatment of Open-Angle Glaucoma: A Long-Term Report of 201 Eyes. Clin Ophthalmol. 2023 Jun 6;17:1619-1627. doi: 10.2147/OPTH.S405837. eCollection 2023.

    PubMed 37304331
  • Pantalon A, Feraru C, Tarcoveanu F, Chiselita D. Success of Primary Trabeculectomy in Advanced Open Angle Glaucoma. Clin Ophthalmol. 2021 May 27;15:2219-2229. doi: 10.2147/OPTH.S308228. eCollection 2021.

    PubMed 34079219
  • Weinreb RN, Aung T, Medeiros FA. The pathophysiology and treatment of glaucoma: a review. JAMA. 2014 May 14;311(18):1901-11. doi: 10.1001/jama.2014.3192.

    PubMed 24825645
  • Zhang N, Wang J, Li Y, Jiang B. Prevalence of primary open angle glaucoma in the last 20 years: a meta-analysis and systematic review. Sci Rep. 2021 Jul 2;11(1):13762. doi: 10.1038/s41598-021-92971-w.

    PubMed 34215769
  • Tham YC, Li X, Wong TY, Quigley HA, Aung T, Cheng CY. Global prevalence of glaucoma and projections of glaucoma burden through 2040: a systematic review and meta-analysis. Ophthalmology. 2014 Nov;121(11):2081-90. doi: 10.1016/j.ophtha.2014.05.013. Epub 2014 Jun 26.

    PubMed 24974815

Questions about this trial

What is this clinical trial studying?

A study testing Trabeculectomy and Slow coagulation trans-scleral cyclophotocoagulation in people with Glaucoma, Open Angle, run by Minia 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 5 inclusion and 3 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 25 Sep 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 Hazem M Abdelaziz, Master (01010045499, hazem.m.abdelaziz@mu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

evaluate and compare the amount of iop reduction between SC-TSCPC and trabeculectomy with MMC in the management of medically uncontrolled OAG in pseudophakic eyes. (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07152132, which also lists 16 linked publications.

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 25 Sep 2025.

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