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CompletedNCT04116450Updated Oct 4, 2019

MicrocatheterTrabeculotomy in Primary Congenital Glaucoma

An interventional study of Glaucolight illuminated microcatheter. in Primary Congenital Glaucoma, sponsored by Minia University. Completed at 1 site in Egypt. Open to participants aged 2 Months to 48 Months. Per ClinicalTrials.gov, last updated 2019-10-04.

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

From the registry’s dates

  • Registered 2 years 4 months after the study started (first participant enrolled Jun 2017, registered Oct 2019).
Phase
Not applicable
Study type
Interventional
Enrollment
25
Allocation
Not applicable
Ages
2 Months to 48 Months
Sex
All
01

Study summary

PURPOSE: To study circumferential trabeculotomy for congenital glaucoma using Glaucolight illuminated microcatheter.

Setting: Ophthalmology department, Faculty of Medicine, Minia University, 61519, El-Minia, Egypt.

DESIGN: Prospective, randomized, consecutive interventional study

METHODS:

This was a prorospective study of 25 eyes of 25 patients with primary congenital or juvenile glaucoma those underwent circumferential trabeculotomy done with an illuminated microcatheter through a period of 24 months. Patients data of 12 months follow-up were recorded. The primary target was mean intraocular pressure (IOP) study in which unqualified (complete success) was defined as an IOP ≤21 mm Hg and at least a 30% reduction without the use of antiglaucoma drugs and a qualified success when medications were used to reach this aim. The secondary target was studding the corneal diameter (CD) and cup disc ratio (C/D) change.

Read the detailed description

Subjects and Methods This was a prorospective study of 25 eyes of 25 patients with primary congenital or juvenile glaucoma those underwent circumferential 360° trabeculotomy done with an illuminated microcatheter (DORC International, Zuidland, Netherlands) through a period of 24 months from June 2017 to May 2019. The child parents were informed by the procedure and signed a consent as well as the study was approved from Ethical Committees and was in accordance with the Declaration of Helsinki.

inclusion criteria: The study included children aged below 6 years with PCG with or without antiglaucoma medications and not had previous antiglaucoma surgery with successful 360°trabeculotomy.

Exclusion criteria: Eyes that needs combined operation, previous antiglaucoma procedure and incomplete trabeculotomy ≤360°.

Preoperative examinations: Routine ocular examination or under general anesthesia for younger children were done after history taking including, age, sex, laterality, family history and consanguinity, antiglaucoma drugs. The ocular examinations includes IOP with Goldman applanation or Perkins tonometer, slit lamp, corneal clarity, measurement of horizontal corneal diameter, axial length by ultrasonography and fundus examination and measurement of cup disc ratio. The demographic data were registered as in (Table 1).

Surgical procedure:

Under general anesthesia, routine ophthalmology srcupping and sterilization. Eye speculum was inserted then

  • Conjunctival peritomy with fornix based flap was done.
  • Superficial rectangular scleral flab 3.5 x 4.5 mm and deep scleral flab 2 x 3 mm with deroofing of Sclemm's canal anteriorly to the scleral spur were done.
  • Cutting Sclemm's canal and exposure of its ostia and dilatation of the ostia by injection of Healon.
  • Paracentesis to lower IOP and injection of Miochol for miosis and Healon to keep anterior chamber stable and deep.
  • Introducing the illuminated catheter into one of the Sclemm's canal ostium and advanced through the whole Sclemm's canal 360° circumference.
  • When the atraumatic tip of the catheter appeared from the other ostium, both ends were pulled in opposite direction to make 360° trabeculotomy.
  • Both Scleral flaps were closed with interrupted 10/0 nylon suture and Conjunctival flap with contentious 10/0 nylon suture.
  • Injection of subconjunctival steroid and antibiotic, then eye dressing.

Post-operative management :

The patients were prescribed topical tobradex( tobramycin- dexamethasone) eye drops QID and tapering through 4-6 weeks and topical cycloplegic eye drops TID for 3 days. Scheduled follow up visits were advised next postoperative day, one week, monthly for three months then each three months till one year. Each visit the child subjected to full ophthalmological examinations previously mentioned and antiglaucoma medications were prescribed when needed (IOP\<21 mmHg) or appearing of signs of glaucoma progression starting by one drug beta blockers and adding dorzolamide or prostaglandin to reach the target IOP.

Patients data of 12 months follow-up were recorded. The primary target was mean intraocular pressure (IOP) study in which unqualified (complete success) was defined as an IOP ≤21 mm Hg and at least a 30% reduction without the use of antiglaucoma drugs, a qualified success when medications were used to reach this aim and failure if the target IOP would not reached in spite of full antiglaucoma medication and the child needs another antiglaucoma procedure. The secondary target was studding the corneal diameter (CD) and cup disc ratio (C/D) change. The results of one week, 3 months, 6 months and one year were included in the statistical analysis.

statistical analysis: Data were collected, revised, verified, coded, then entered PC for statistical analysis done by using SPSS statistical package version 20. Descriptive statistics for quantitative data: mean (X) and standard deviation (SD). Kolmogorov- Smirnov for normality test was used to differentiate between parametric data and non-parametric data. Statistical analysis using Wilcoxon signed ranks test for comparison of two related parameters preoperative and postoperative. For all tests probability (P value) was considered non-significant if ≥ 0.05, significant if \< 0.05, highly significant if \< 0.01 and very highly significant if \<0.001.

02

Conditions studied

  • Primary Congenital Glaucoma
03

In context

Glaucoma

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

This study's enrollment of 25 is below the median of 65 across 1,272 interventional studies indexed under Glaucoma.

Browse Glaucoma studies →

Lead sponsor

Minia University is the lead sponsor of 356 studies on the registry; 115 are open to participants now.

Of its 6 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
2 Months to 48 Months
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • The study included children aged below 6 years with PCG with or without antiglaucoma medications and not had previous antiglaucoma surgery with successful 360°trabeculotomy.

Exclusion criteria

Exclusion Criteria:

  • Eyes that needs combined operation, previous antiglaucoma procedure and incomplete trabeculotomy ≤360°.
05

Study design

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

Study arms

  • Other
    primary congenital glaucoma

    Glaucolight illuminated microcatheter trabeculotomy in primary congenital glaucoma

    Procedure: Glaucolight illuminated microcatheter.

Interventions

  • ProcedureGlaucolight illuminated microcatheter.

    To study circumferential trabeculotomy for congenital glaucoma using Glaucolight illuminated microcatheter.

    Also known as: circumferential trabeculotomy for congenital glaucoma using Glaucolight illuminated microcatheter.

06

What researchers measure

Primary outcomes

  1. Intra-ocular pressure

    The primary target was mean intraocular pressure (IOP) study in which unqualified (complete success) was defined as an IOP ≤21 mm Hg and at least a 30% reduction without the use of antiglaucoma drugs and a qualified success when medications were used to reach this aim.

    Time frame: one year

Secondary outcomes

  1. corneal diameer

    The secondary target was studding the corneal diameter (CD)

    Time frame: 1 year

  2. cup discratio

    cup disc ratio (C/D) change.

    Time frame: 1 year

07

Study locations

1 site
  • Minia University
    Minya, 61519, Egypt
08

References and documents

Publications

  • El Sayed Y, Gawdat G. Two-year results of microcatheter-assisted trabeculotomy in paediatric glaucoma: a randomized controlled study. Acta Ophthalmol. 2017 Dec;95(8):e713-e719. doi: 10.1111/aos.13414. Epub 2017 Mar 7. PubMed 28266150 ↗
  • Morales J, Al Shahwan S, Al Odhayb S, Al Jadaan I, Edward DP. Current surgical options for the management of pediatric glaucoma. J Ophthalmol. 2013;2013:763735. doi: 10.1155/2013/763735. Epub 2013 Apr 24. PubMed 23738051 ↗

Individual participant data

Plan to share: No — freely share

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 4, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04116450
Lead sponsor
Minia University
Responsible party
Shaaban Elwan (Assistant professor of ophthalmology, Minia University) — Principal investigator
First posted
Oct 4, 2019
Start date
Jun 1, 2017
Primary completion
May 31, 2019
Completion
May 31, 2019
Last update
Oct 4, 2019

Study contacts

mahmoud M Genaidy, MD
study director · Minia University

Oversight

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

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