MicrocatheterTrabeculotomy in Primary Congenital Glaucoma
Condition: Primary Congenital Glaucoma
MeSH terms: Glaucoma; Hydrophthalmos
Study type: Interventional

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.
    

Intervention name(s): Glaucolight illuminated microcatheter.
Intervention type(s): Procedure
Intervention description(s): To study circumferential trabeculotomy for congenital glaucoma using Glaucolight illuminated microcatheter.
Other intervention name(s): circumferential trabeculotomy for congenital glaucoma using Glaucolight illuminated microcatheter.
Intervention model: Single Group Assignment
Intervention model description: 25 patient underwent Glaucolight illuminated microcatheter for primary congenital glaucoma
Masking: None (Open Label)
Primary purpose: Treatment