MicrocatheterTrabeculotomy in Primary Congenital Glaucoma
Primary Purpose
Primary Congenital Glaucoma
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Glaucolight illuminated microcatheter.
Sponsored by

About this trial
This is an interventional treatment trial for Primary Congenital Glaucoma
Eligibility Criteria
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°.
Sites / Locations
- Minia University
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
primary congenital glaucoma
Arm Description
Glaucolight illuminated microcatheter trabeculotomy in primary congenital glaucoma
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
corneal diameer
The secondary target was studding the corneal diameter (CD)
cup discratio
cup disc ratio (C/D) change.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04116450
Brief Title
MicrocatheterTrabeculotomy in Primary Congenital Glaucoma
Official Title
Microcatheter Assisted Circumferential Trabeculotomy in Congenital Glaucoma
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
June 1, 2017 (Actual)
Primary Completion Date
May 31, 2019 (Actual)
Study Completion Date
May 31, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Minia University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Congenital Glaucoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
25 patient underwent Glaucolight illuminated microcatheter for primary congenital glaucoma
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
primary congenital glaucoma
Arm Type
Other
Arm Description
Glaucolight illuminated microcatheter trabeculotomy in primary congenital glaucoma
Intervention Type
Procedure
Intervention Name(s)
Glaucolight illuminated microcatheter.
Other Intervention Name(s)
circumferential trabeculotomy for congenital glaucoma using Glaucolight illuminated microcatheter.
Intervention Description
To study circumferential trabeculotomy for congenital glaucoma using Glaucolight illuminated microcatheter.
Primary Outcome Measure Information:
Title
Intra-ocular pressure
Description
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 Outcome Measure Information:
Title
corneal diameer
Description
The secondary target was studding the corneal diameter (CD)
Time Frame
1 year
Title
cup discratio
Description
cup disc ratio (C/D) change.
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Months
Maximum Age & Unit of Time
48 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
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°.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
mahmoud M Genaidy, MD
Organizational Affiliation
Minia University
Official's Role
Study Director
Facility Information:
Facility Name
Minia University
City
Minya
ZIP/Postal Code
61519
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
freely share
Citations:
PubMed Identifier
28266150
Citation
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.
Results Reference
background
PubMed Identifier
23738051
Citation
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.
Results Reference
background
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MicrocatheterTrabeculotomy in Primary Congenital Glaucoma
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