NCT07152132

Brief Summary

cyclodiode versus trabeculectomy with MMC in pseudophakic patients.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
8mo left

Started Jul 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress55%
Jul 2025Dec 2026

Study Start

First participant enrolled

July 20, 2025

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

August 7, 2025

Completed
27 days until next milestone

First Posted

Study publicly available on registry

September 3, 2025

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2026

Last Updated

September 25, 2025

Status Verified

September 1, 2025

Enrollment Period

1.2 years

First QC Date

August 7, 2025

Last Update Submit

September 22, 2025

Conditions

Keywords

SC-TSCPCTrabeculectomyOAGPseudophakic

Outcome Measures

Primary Outcomes (2)

  • 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.

    6 months

  • 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

    6 months

Study Arms (2)

25 patients will undergo trabeculectomy with MMC (group B).

ACTIVE COMPARATOR

25 patients will undergo trabeculectomy with MMC (group B).

Procedure: Trabeculectomy

25 patients will be subjected to SC-TSCPC (group A)

ACTIVE COMPARATOR

25 patients will be subjected to SC-TSCPC (group A)

Procedure: Slow coagulation trans-scleral cyclophotocoagulation

Interventions

Trabeculectomy with mitomycin c application

25 patients will undergo trabeculectomy with MMC (group B).

Slow coagulation trans-scleral cyclophotocoagulation

25 patients will be subjected to SC-TSCPC (group A)

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • \. 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.
  • \. Patients with ocular diseases as uveitis. 5. Patients with severe ocular surface disorders as ocular cicatricial pemphigoid.
  • \. Aphakic patients. 7. Ocular interventions apart from YAG posterior capsulotomy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Minia University Hospital

Minya, 61111, Egypt

RECRUITING

Related Publications (16)

  • 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.

    PMID: 12271364BACKGROUND
  • 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.

    PMID: 11231767BACKGROUND
  • 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.

    PMID: 32672611BACKGROUND
  • 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.

    PMID: 33429109BACKGROUND
  • 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.

    PMID: 35200163BACKGROUND
  • 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.

    PMID: 32632402BACKGROUND
  • 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.

    PMID: 32821494BACKGROUND
  • 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.

    PMID: 28237137BACKGROUND
  • 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.

    PMID: 28371125BACKGROUND
  • 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.

    PMID: 21320958BACKGROUND
  • 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.

    PMID: 37304331BACKGROUND
  • 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.

    PMID: 34079219BACKGROUND
  • 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.

    PMID: 24825645BACKGROUND
  • 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.

    PMID: 34215769BACKGROUND
  • 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.

    PMID: 24974815BACKGROUND
  • Melik Parsadaniantz S, Reaux-le Goazigo A, Sapienza A, Habas C, Baudouin C. Glaucoma: A Degenerative Optic Neuropathy Related to Neuroinflammation? Cells. 2020 Feb 25;9(3):535. doi: 10.3390/cells9030535.

    PMID: 32106630BACKGROUND

MeSH Terms

Conditions

Glaucoma, Open-Angle

Interventions

Trabeculectomy

Condition Hierarchy (Ancestors)

GlaucomaOcular HypertensionEye Diseases

Intervention Hierarchy (Ancestors)

Filtering SurgeryOphthalmologic Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Ahmed M Eid, MD

    Minia University Hospital

    STUDY DIRECTOR

Central Study Contacts

Hazem M Abdelaziz, Master

CONTACT

Mohamed Tarek M Abdelkader, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assisstant lecture

Study Record Dates

First Submitted

August 7, 2025

First Posted

September 3, 2025

Study Start

July 20, 2025

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

December 30, 2026

Last Updated

September 25, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations