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Primary Congenital GlaucomaNCT04116450

MicrocatheterTrabeculotomy in Primary Congenital Glaucoma

A study testing Glaucolight illuminated microcatheter. in people with Primary Congenital Glaucoma, run by Minia University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 2 to 48 months
Conditions the study is for
Primary Congenital Glaucoma
What is being tested?
Glaucolight illuminated microcatheter.
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
1 siteEgypt
Study dates
1 Jun 2017to 31 May 2019
Phase
Interventional
Are there results?
None posted in the registry

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 2 to 48 months
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Minia University

    Minya, 61519

Other trials in Egypt

About this study

Official title: Microcatheter Assisted Circumferential Trabeculotomy in Congenital Glaucoma

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

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

Read more

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.

Being tested
Glaucolight illuminated microcatheter.
Medical subject headings
Hydrophthalmos

What participants receive

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

  • Glaucolight illuminated microcatheter.Procedure or surgery

    Also called circumferential trabeculotomy for congenital glaucoma using Glaucolight illuminated microcatheter.

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

Study groups in NCT04116450
Study groupRoleWhat they receive
primary congenital glaucomaOtherGlaucolight illuminated microcatheter trabeculotomy in primary congenital glaucoma
Receives: Procedure: Glaucolight illuminated microcatheter.

What is being measured

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

  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.

    Measured: one year

Secondary outcomes (2)
  1. corneal diameer

    The secondary target was studding the corneal diameter (CD)

    Measured: 1 year

  2. cup discratio

    cup disc ratio (C/D) change.

    Measured: 1 year

Timeline

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

  1. First posted4 Oct 2019
  2. Study start1 Jun 2017
  3. Primary completion31 May 2019
  4. Study completion31 May 2019

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
Not applicable
Intervention model
Single group
Model description
25 patient underwent Glaucolight illuminated microcatheter for primary congenital glaucoma
Masking
None (open label)
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04116450
Sponsor's protocol ID
Minia U, Glaucoma unit
Status last verified
Oct 2019
First submitted
1 Oct 2019
Last updated
4 Oct 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: freely share

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

Questions about this trial

What is this clinical trial studying?

A study testing Glaucolight illuminated microcatheter. in people with Primary Congenital Glaucoma, 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 4 Oct 2019. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Intra-ocular pressure (time frame: one year). 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 NCT04116450, which also lists 2 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 4 Oct 2019.

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