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Status unknownNCT05530031UBMUpdated Sep 7, 2022

UBM Guided Site and Extent of Trabeculotomy in Pediatric Glaucoma

An interventional study of trabeculotomy ( angle glaucoma surgery ) in Glaucoma Pediatric, sponsored by Mansoura University. Status unknown at 1 site in Egypt. Open to participants aged Up to 18 Years. Per ClinicalTrials.gov, last updated 2022-09-07.

Sponsored by Mansoura University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Sep 2022), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Not applicable
Ages
Up to 18 Years
Sex
All
01

Study summary

Different types of surgery are applied in PCG, including goniotomy, trabeculotomy, glaucoma drainage devices and trabeculectomy. UBM examination of the anterior chamber before surgery can help in the decision to what type of surgery is best for the patient. Aim of the work To study the value of using UBM to select the site and extent of trabeculotomy in pediatric glaucoma and its correlation with surgical outcomes.

Read the detailed description

To study the value of using UBM to select the site and extent of trabeculotomy in pediatric glaucoma and its correlation with surgical outcomes.All Cases with pediatric glaucoma prepared for trabeculotomy including Primary congenital glaucoma and secondary glaucoma as : glaucoma following cataract surgery and traumatic glaucoma Methods

History taking:

  • Family history of ocular pathologies or syndromes.
  • Age at which the mother noticed ocular affection, time and type of intervention.
  • Onset of IOP elevation, IOP lowering medications used and any previous surgical intervention for glaucoma.

Preoperative examination \& assessment

  • Examination under anaesthesia for state of the conjunctiva, conreal incision scars, corneal diameter, Haab's stria, broad limbus, anterior chamber depth, regularity and content, pupil shape, centration and response to mydriatics, IOL position and status in pseudophakic cases, IOP value, optic nerve cupping.
  • A scan for axial length and central corneal thickness.
  • B scan ultrasonography.
  • UBM : full detailed anterior segment examination will be done including : trabecular iris angle width , presence of abnormal iris insertion , abnormal membranes , Schlemm canal studying and iris thickness. All these parameters will be recorded for all 4 quadrants to select the most appropriate site of trabeculotomy.

Procedure

  • trabeculotomy (with Metal Trabeculotome): a scleral flap is raised at the selected site with UBM and a cutdown in shlemm's canal is performed, a metal trabeculotome is used to cannulate and tear through a section of the inner wall of SC and trabeculum into the AC. Closure of the scleral flap and conjunctiva with 10/0 nylon. Viscoelastic is used to dilate the schlemm's canal, form the anterior chamber and decrease the risk of hyphema.

Follow up

  • Postoperative visits planned on the first day, first week, second week, at first month, three months and six months.
  • Outcome measures included the IOP value at each visit, corneal diameters, cup disc ratio if accessible, the number of glaucoma medications used, the number and kind of complications.
  • Surgical success was defined as:

    1. Complete sucess when IOP >5mmHg and ≤21mmHg or 30% IOP reduction from baseline and without any further IOP-lowering surgery.
    2. Qualitative success when IOP ≤21mmHg or 30% IOP reduction from baseline but with the use of IOP lowering medications.
  • Failure is defined as:
  • IOP more than 21mmHg despite the use of IOP lowering medications.
  • Hypotony: IOP ≤5mmHg persistent for more than two weeks.
  • Need for other glaucoma surgery to control IOP.
02

Conditions studied

  • Glaucoma Pediatric

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03

In context

Glaucoma

1,818 studies on the registry are indexed under Glaucoma; 231 are open to participants now.

This study's planned enrollment of 40 is below the median of 65 across 1,272 interventional studies indexed under Glaucoma.

Browse Glaucoma studies →

Lead sponsor

Mansoura University is the lead sponsor of 1,077 studies on the registry; 183 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • All Cases with pediatric glaucoma prepared for trabeculotomy including Primary congenital glaucoma and secondary glaucoma as : glaucoma following cataract surgery and traumatic glaucoma

Exclusion criteria

Exclusion Criteria:

patients refusing the study

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    pediatric glaucoma patients either primary or secondary

    All Cases with pediatric glaucoma prepared for trabeculotomy including Primary congenital glaucoma and secondary glaucoma as : glaucoma following cataract surgery and traumatic glaucoma

    Procedure: trabeculotomy ( angle glaucoma surgery )

Interventions

  • Proceduretrabeculotomy ( angle glaucoma surgery )

    a scleral flap is raised at the selected site with UBM and a cutdown in shlemm's canal is performed, a metal trabeculotome is used to cannulate and tear through a section of the inner wall of SC and trabeculum into the AC. Closure of the scleral flap and conjunctiva with 10/0 nylon. Viscoelastic is used to dilate the schlemm's canal, form the anterior chamber and decrease the risk of hyphema.

06

What researchers measure

Primary outcomes

  1. Intraocular pressure

    success of glaucoma surgery

    Time frame: 6 months

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No — results

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 7, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05530031
Lead sponsor
Mansoura University
Responsible party
Dina abdelfattah (Dina Abd Elfattah, Mansoura University) — Principal investigator
First posted
Sep 7, 2022
Start date
Sep 2022 (estimated)
Primary completion
Jan 2023 (estimated)
Completion
Jun 2023 (estimated)
Last update
Sep 7, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.

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