AzTrials
AzTrials

Iris IncarcerationNCT04129463

Subscleral Trabeculectomy With Iris Incarceration in Buphthalmous

A study testing Subscleral Trabeculectomy (SST) with Iris incarceration and Conventional trabeculotomy in people with Iris Incarceration, run by Shaaban Elwan at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 2 to 12 months
Conditions the study is for
Iris Incarceration
What is being tested?
Subscleral Trabeculectomy (SST) with Iris incarceration and Conventional trabeculotomy
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
1 siteEgypt
Study dates
Jan 2015to 25 Feb 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 2 to 12 months
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Minia University

    Minya

Other trials in Egypt

About this study

Official title: SST With Iris Incarceration in Buphthalmous

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.

Being tested
Subscleral Trabeculectomy (SST) with Iris incarceration, Conventional trabeculotomy
Keywords
Buphthalmous, Iris incarceration, SST, IOP, AXL

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Subscleral Trabeculectomy (SST) with Iris incarcerationDevice

    Also called Group1

    Subscleral Trabeculectomy with Iris Incarceration using iris forceps and scissors

  • Conventional trabeculotomyDevice

    Also called Group 2

    Conventional trabeculotomy in Buphthalmous using rigid Hans trabeculotome

Study groups in NCT04129463
Study groupRoleWhat they receive
SST with Iris incarcerationActive comparatorinfants that underwent SST with iris incarceration procedure
Receives: Device: Subscleral Trabeculectomy (SST) with Iris incarceration
Conventional trabeculotomyActive comparatorinfants that underwent Conventional trabeculotomy
Receives: Device: Conventional trabeculotomy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. IOP reduction

    Intra-ocular pressure change in mmHg

    Measured: 2 years

Secondary outcomes (3)
  1. Corneal diameter

    Corneal diameter change in mm

    Measured: 2 years

  2. Cup/ disc change

    Cup/ disc change in mm

    Measured: 2 years

  3. AXL change

    Axial length change in mm

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Oct 2019
  2. Study startJan 2015
  3. Primary completionFeb 2019
  4. Study completion25 Feb 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Group 1 SST with iris incarceration and group2 conventional trabeculotomy
Masking
None (open label)
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04129463
Sponsor's protocol ID
Minia University, SST
Status last verified
Oct 2019
First submitted
14 Oct 2019
Last updated
16 Oct 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Data share

Questions about this trial

What is this clinical trial studying?

A study testing Subscleral Trabeculectomy (SST) with Iris incarceration and Conventional trabeculotomy in people with Iris Incarceration, run by Shaaban Elwan at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

IOP reduction (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2019; AzTrials last refreshed its copy on 4 Nov 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in