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.
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.
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.
- Conditions
- Iris Incarceration
- 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 group | Role | What they receive |
|---|---|---|
| SST with Iris incarceration | Active comparator | infants that underwent SST with iris incarceration procedure Receives: Device: Subscleral Trabeculectomy (SST) with Iris incarceration |
| Conventional trabeculotomy | Active comparator | infants 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.
IOP reduction
Intra-ocular pressure change in mmHg
Measured: 2 years
Secondary outcomes (3)
Corneal diameter
Corneal diameter change in mm
Measured: 2 years
Cup/ disc change
Cup/ disc change in mm
Measured: 2 years
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.
- First posted16 Oct 2019
- Study startJan 2015
- Primary completionFeb 2019
- Study completion25 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iris IncarcerationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Shaaban Elwan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Shaaban Elwan, Minia University
- Investigators
- Shaaban AM Elwan, MD, Principal investigator, Minia University
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
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SST With Iris Incarceration in Buphthalmous
- ClinicalTrials.gov ID
- NCT04129463
- Acronym / sponsor ID
- Minia University, SST
- Conditions
- Iris Incarceration
- Keywords
- Buphthalmous, Iris incarceration, SST, IOP, AXL
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Shaaban ElwanUniversity, hospital or other
- Study start
- Jan 2015 (actual)
- Primary completion
- Feb 2019 (actual)
- Study completion
- 25 Feb 2019 (actual)
- First posted
- 16 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Group 1 SST with iris incarceration and group2 conventional trabeculotomy
| Arm | Type | Receives |
|---|---|---|
| SST with Iris incarceration | Active comparator | Device: Subscleral Trabeculectomy (SST) with Iris incarcerationinfants that underwent SST with iris incarceration procedure |
| Conventional trabeculotomy | Active comparator | Device: Conventional trabeculotomyinfants that underwent Conventional trabeculotomy |
Who may qualify
- Ages
- 2 to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- The study included infants aged below ≤ 1 year with Buphthalmous with or without antiglaucoma medications and not had previous antiglaucoma surgery.
- -
Key exclusion criteria (1 listed)
- Eyes that had previous antiglaucoma procedure or eyes that need combined operation and infants not fit for GA.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Subscleral Trabeculectomy (SST) with Iris incarcerationAlso: Group1Subscleral Trabeculectomy with Iris Incarceration using iris forceps and scissors | Device | SST with Iris incarceration |
| Conventional trabeculotomyAlso: Group 2Conventional trabeculotomy in Buphthalmous using rigid Hans trabeculotome | Device | Conventional trabeculotomy |
Primary outcome
IOP reduction
Time frame: 2 years
Intra-ocular pressure change in mmHg
3 secondary outcomes
Corneal diameter
Time frame: 2 years
Cup/ disc change
Time frame: 2 years
AXL change
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2019.
- Individual participant dataSharing planned: Yes. Data share
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shaaban AM Elwan, MD principal investigator
Minia University
1 site in 1 country: see every site and its status.
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.