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CompletedNCT04129463Updated Oct 16, 2019

Subscleral Trabeculectomy With Iris Incarceration in Buphthalmous

An interventional study of Subscleral Trabeculectomy (SST) with Iris incarceration and Conventional trabeculotomy in Iris Incarceration, sponsored by Shaaban Elwan. Completed at 1 site in Egypt. Open to participants aged 2 Months to 12 Months. Per ClinicalTrials.gov, last updated 2019-10-16.

Sponsored by Shaaban Elwan · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 4 years 9 months after the study started (first participant enrolled Jan 2015, registered Oct 2019).
Phase
Not applicable
Study type
Interventional
Enrollment
25
Allocation
Randomized
Ages
2 Months to 12 Months
Sex
All
01

Study 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)

Read the 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.

02

Conditions studied

  • Iris Incarceration

Keywords

  • Buphthalmous
  • Iris incarceration
  • SST
  • IOP
  • AXL
03

In context

Lead sponsor

Shaaban Elwan is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Months to 12 Months
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

The study included infants aged below ≤ 1 year with Buphthalmous with or without antiglaucoma medications and not had previous antiglaucoma surgery.

Exclusion criteria

-

Exclusion Criteria:

  • Eyes that had previous antiglaucoma procedure or eyes that need combined operation and infants not fit for GA.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
25 participants (actual)

Study arms

  • Active comparator
    SST with Iris incarceration

    infants that underwent SST with iris incarceration procedure

    Device: Subscleral Trabeculectomy (SST) with Iris incarceration

  • Active comparator
    Conventional trabeculotomy

    infants that underwent Conventional trabeculotomy

    Device: Conventional trabeculotomy

Interventions

  • DeviceSubscleral Trabeculectomy (SST) with Iris incarceration

    Subscleral Trabeculectomy with Iris Incarceration using iris forceps and scissors

    Also known as: Group1

  • DeviceConventional trabeculotomy

    Conventional trabeculotomy in Buphthalmous using rigid Hans trabeculotome

    Also known as: Group 2

06

What researchers measure

Primary outcomes

  1. IOP reduction

    Intra-ocular pressure change in mmHg

    Time frame: 2 years

Secondary outcomes

  1. Corneal diameter

    Corneal diameter change in mm

    Time frame: 2 years

  2. Cup/ disc change

    Cup/ disc change in mm

    Time frame: 2 years

  3. AXL change

    Axial length change in mm

    Time frame: 2 years

07

Study locations

1 site
  • Minia University
    Minya, Egypt
08

References and documents

Individual participant data

Plan to share: Yes — Data share

Supporting information: Csr

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 16, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04129463
Lead sponsor
Shaaban Elwan
Responsible party
Shaaban Elwan (Assistant professor of ophthalmology, Minia University) — Sponsor-investigator
First posted
Oct 16, 2019
Start date
Jan 2015
Primary completion
Feb 2019
Completion
Feb 25, 2019
Last update
Oct 16, 2019

Study contacts

Shaaban AM Elwan, MD
principal investigator · 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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