SST With Iris Incarceration in Buphthalmous
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 25
- Locations
- 1
- Primary Endpoint
- IOP reduction
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 2 Months to 12 Months (Child)
- Sex
- 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
- •Eyes that had previous antiglaucoma procedure or eyes that need combined operation and infants not fit for GA.
Arms & Interventions
SST with Iris incarceration
infants that underwent SST with iris incarceration procedure
Intervention: Subscleral Trabeculectomy (SST) with Iris incarceration (Device)
Conventional trabeculotomy
infants that underwent Conventional trabeculotomy
Intervention: Conventional trabeculotomy (Device)
Outcomes
Primary Outcomes
IOP reduction
Time Frame: 2 years
Intra-ocular pressure change in mmHg
Secondary Outcomes
- Corneal diameter(2 years)
- AXL change(2 years)
- Cup/ disc change(2 years)
Investigators
Shaaban Elwan
Assistant professor of ophthalmology
Minia University
