Subscleral Trabeculectomy With Iris Incarceration in Buphthalmous
Condition: Iris Incarceration
Study type: Interventional

Summary: 
      Purpose: To evaluate a new modification for surgical treatment of Buphthalmous using
      subscleral trabeculectomy (SST) with iris incarceration Design: Prospective, randomized,
      consecutive interventional comparative study. Setting: Ophthalmology department, Faculty of
      Medicine, Minia University, 61519, El-Minia, Egypt.

      Patients and Methods:

      This was a prospective study of eyes of 40 eyes with buphthalmous in 25 child 15 bilateral
      and 10 with unilateral Buphthalmous divided into 2 groups. Group 1 (20 eyes ) those underwent
      subscleral trabeculectomy (SST) with iris incarceration a new modification to SST and group 2
      conventional rigid trabeculotomy through a period of 4 years between Jan., 2015 and Feb.,
      2019. Patient's data of 2 years follow-up were recorded. The primary outcomes were the mean
      intraocular pressure (IOP) control in which complete success was defined as an IOP ≤18 mm Hg
      without the use of anti-glaucoma drugs and a qualified success when medications were used to
      reach this target and times of another surgical interference till reach IOP control. The
      secondary outcomes were studding bleb formation, the change in corneal diameter (CD), cup
      disc ratio (C/D) , and axial length (AXL)
    

Detailed description: 
      Subjects and Methods This was a prospective study of eyes of 40 eyes with Buphthalmous in 25
      infants (15 bilateral and 10 with unilateral) divided into 2 groups. Group 1 (20 eyes) those
      underwent Subscleral trabeculectomy (SST) with iris incarceration a new modification to SST
      and group 2 conventional rigid trabeculotomy through a period of 4 years between Jan., 2015
      and Feb., 2019. The local board committee approved the study as well as all patients'
      relatives signed consent and the study was in agreement with Declaration of Helsinki Tents.
      The primary outcomes were the mean intraocular pressure (IOP) measured under General
      Anesthesia (GA) and the number of repeated surgical intervention. Complete success was
      defined as an IOP ≤18 mm Hg without the use of anti-glaucoma drugs, a qualified success when
      medications were used to reach this target and failure if the target IOP would not be reached
      in spite of full anti-glaucoma medication and the infant needs another anti-glaucoma
      procedure and the number of repeated surgical intervention were recorded. The secondary
      outcomes were studding bleb formation, the change in corneal diameter (CD), cup disc ratio
      (C/D), and axial length (AXL).

      Preoperative examinations: History taking including, age, sex, laterality, family history and
      consanguinity, anti-glaucoma drugs. Ophthalmological examinations were done under GA,
      includes slit lamp examination, corneal clarity, horizontal corneal diameter, fundus
      examination and measurement of cup disc ratio, IOP with Perkins tonometer, and axial length
      by ultrasonography. The demographic data were registered as in (Table 1).

      Surgical procedure:

      All procedures were done by one of the Authors under GA. In group 1 SST with iris
      incarceration Steps in brief:-

        -  Clear corneal traction suture by vicryl 7/0 in the superior peripheral part 1 mm from
           the limbus

        -  Conjunctival peritomy with fornix based conjunctival flap was done in the upper temporal
           quadrant.

        -  Half thickness rectangular scleral flab 3.5 x 4.5 mm was constructed.

        -  Paracentesis to lower IOP and allows reformation of anterior chamber when needed and
           check filtration.

        -  Block trabeculectomy were done manually by knife and vannas scissors.

        -  Iris incarceration was done by cutting the iris into 2 pillars, one pillar incarcerated
           under the scleral flap and the other one reposted with iris repositor resulting in
           inverted coma shaped pupil.

        -  Scleral flap was closed with interrupted 10/0 nylon suture and Conjunctival flap with
           contentious 10/0 nylon suture then injection of subconjunctival steroid, antibiotic and
           eye dressing.

      In group 2 trabeculotomy Steps in brief:-

        -  Conjunctival peritomy with fornix based Conjunctival flap was done in the upper temporal
           quadrant.

        -  Superficial rectangular scleral flab 3.5 x 4.5 mm and then small triangular deep scleral
           flab (modified technique) with deroofing of Schlemm's canal anteriorly to the scleral
           spur were done.

        -  Radial incision into the scleral bed and cutting Schlemm's canal, exposure of its
           opening and dilatation of the ostia by injection of Healon or trabeculotome.

        -  Paracentesis to lower IOP allows reformation of anterior chamber when needed and check
           filtration.

        -  Hans's trabeculotome was inserted into Schlemm's canal from one side and centripetal
           rupture of the canal through trabecular meshwork into the anterior chamber about 70- 90
           degree and repeated on the other side.

        -  Scleral flap was closed with interrupted 10/0 nylon suture and Conjunctival flap with
           contentious 10/0 nylon suture then injection of subconjunctival steroid, antibiotic and
           eye dressing

      Post-operative management:

      The patients were prescribed topical tobradex (tobramycin- dexamethasone) eye drops QID and
      tapering through 4-6 weeks and Vigamox (moxifloxacin 0.3 mg, Alcon Co) eye drops QID for 2
      weeks. Scheduled follow up visits were advised next postoperative day, one week, monthly for
      three months then each three months for 2 years. Each visit the child subjected to full
      ophthalmological examinations previously mentioned and antiglaucoma medications were
      prescribed when needed (IOP>18 mmHg) or glaucoma progression starting by one drug beta
      blockers and adding dorzolamide or prostaglandin to reach the target IOP. Another glaucoma
      procedure were done if the IOP > 18 mmHg with maximum tolerated medication. Patient's data of
      the 2 years follow-up were recorded. The results of one week, 1 month, 3 months, 6 months, 1
      year and 2 years were included in the statistical analysis.

      Statistical analysis:

      Data were collected, for statistical analysis done by using SPSS statistical package version
      20. Descriptive statistics for the (mean ±SD) were done. Paired student's t-test was used for
      comparison of two related parameters preoperative and postoperative. For all tests (P value)
      was considered significant if < 0.05.
    

Intervention name(s): Subscleral Trabeculectomy (SST) with Iris incarceration; Conventional trabeculotomy
Intervention type(s): Device; Device
Intervention description(s): Subscleral Trabeculectomy with Iris Incarceration using iris forceps and scissors; Conventional trabeculotomy in Buphthalmous using rigid Hans trabeculotome
Other intervention name(s): Group1; Group 2
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Group 1 SST with iris incarceration and group2 conventional trabeculotomy
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Buphthalmous; Iris incarceration; SST; IOP; AXL