Glaucoma CongenitalNCT05011747
Viscotrabeculotomy in Pediatric Glaucoma Following Cataract Surgery
A study testing single-site rigid probe viscotrabeculotomy (VT) and two-site rigid probe viscotrabeculotomy (VT) in people with Glaucoma Congenital, run by Mansoura University.
Trial summary
Long term Surgical Outcomes of Viscotrabeculotomy in Pediatric Glaucoma Following Cataract Surgery. Purpose: This study aims to compare outcomes of single-site rigid probe viscotrabeculotomy (VT) to two-site VT in pediatric secondary glaucoma following cataract surgery. Read more about this study
- Who is it for?
- Ages 2 months to 12 years
- Conditions the study is for
- Glaucoma Congenital
- What is being tested?
- single-site rigid probe viscotrabeculotomy (VT) and two-site rigid probe viscotrabeculotomy (VT)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Sep 2021to Dec 2024
- 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 months to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- -Patients aged ≤ 12 years and required surgery for glaucoma following congenital cataract surgery (GFCS) with or without intraocular lens (IOL) implantation.
Who cannot join
- Eyes in which the trabeculotomy involves <180° of Schlemm's canal.
- Eyes that have synechial angle closure over ≥ 90°.
- Eyes that have previous procedures other than lensectomy or IOL implantation.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Long Term Surgical Outcomes of Viscotrabeculotomy in Pediatric Glaucoma Following Cataract Surgery
Long term Surgical Outcomes of Viscotrabeculotomy in Pediatric Glaucoma Following Cataract Surgery.
Purpose:
Read more
This study aims to compare outcomes of single-site rigid probe viscotrabeculotomy (VT) to two-site VT in pediatric secondary glaucoma following cataract surgery.
Methods:
This is a comparative study was performed on patients aged ≤ 12 years and required surgery for glaucoma following congenital cataract surgery (GFCS) with or without intraocular lens (IOL) implantation. Eyes in which the trabeculotomy involves <180° of Schlemm's canal ,eyes that have synechial angle closure over ≥ 90° and eyes that have previous procedures other than lensectomy or IOL implantation are excluded from the study. Eyes are then randomized to undergo single-site VT or two-site VT using a random table. The two-site VT by the rigid probe trabeculotome is performed through a superonasal and an inferotemporal triangular scleral flap. Intraocular pressure (IOP), anti-glaucoma medications, complications and success rates at dates of follow up are all reported. Success is defined as IOP between 6-20 mmHg or 35% IOP reduction with or without topical anti-glaucoma medications and without visually-devastating complications or additional glaucoma surgery.
Read the detailed description
Long term Surgical Outcomes of Viscotrabeculotomy in Pediatric Glaucoma Following Cataract Surgery.
Introduction:
Despite advances in congenital cataract management, secondary glaucoma (SG) remains a major postoperative sight-threatening complication, with open-angle glaucoma being the predominant type in both aphakic and pseudophakic children . Although the pathogenesis of glaucoma after cataract surgery remains unclear, several risk factors have been identified. These include early surgery, chronic postoperative inflammation , primary posterior capsulotomy , persistence of fetal vasculature , and microphthalmia .
However, the pathogenesis of the classic, open-angle type of glaucoma that develops on average 1.3-12.2 years following uneventful cataract surgery is still obscure. Mechanical collapse of the trabecular meshwork due to the loss of ciliary body tension could be one of the possible reasons. Some speculate that obstruction of the trabecular meshwork by inflammatory cells, lens remnants and vitreous-derived factors may result in delayed elevation in IOP. Arrest of postnatal angle maturation secondary to the surgical intervention could be a contributing factor, especially that aphakic glaucoma is more likely to occur in patients who had lensectomy at a younger age, usually the first year of life. The incidence of secondary pediatric glaucoma after cataract surgery is not yet precisely identified. It ranges from 3%-41% depending on the follow-up period and the criteria chosen to define glaucoma . Management of paediatric glaucoma following cataract surgery (GFCS) is challenging. Trabeculectomy has a poor success rate and precludes the use of contact lenses, especially in the presence of thin, avascular, cystic blebs . Glaucoma drainage devices have a higher chance of success than trabeculectomy, but aphakic eyes have relatively higher rates of complications, especially suprachoroidal haemorrhage, if hypotony occurs particularly if buphthalmic. GDD-implanted eyes also carry a life-long risk of developing keratopathy secondary to endothelial decompensation from the tube end .Cyclodestructive procedures provide a temporizing treatment with occasional longterm control after multiple treatments. Yet, it is difficult to titrate with marked inflammation and a risk of phthisis, especially in microphthalmic eyes. Furthermore, it may be associated with chronic hypotony and may prejudice future surgery to failure. Angle surgery was first described as a surgical option in GFCS by Chen et al., yielding promising results in terms of IOP lowering and surgical success. Unlike bleb-based procedures, angle surgery addresses the more physiological outflow pathway through the trabecular meshwork and Schlemm's canal. Hence the risk of bleb-based complications such as infection, bleb leak, overfiltration and bleb dysthesia is reduced. With the growing evidence that circumferential trabeculotomy yields superior results to conventional 180° angle surgery in primary congenital glaucoma16, Freedman et al. retrospectively reported the results of microcatheter-assisted circumferential trabeculotomy in GFCS, achieving a 72% success rate. several reports in treatment of pediatric glaucoma have concluded that the use of viscoelastic materials during trabeculotomy may increase the success rate of the procedure by preventing ocular decompression, postoperative hemorrhage, anterior chamber shallowness, and adhesion of the incision lips or fibroblastic proliferation18.The purpose of the present study was to compare outcomes of single-site rigid probe viscotrabeculotomy (VT) Versus two-site VT in pediatric secondary glaucoma following cataract surgery.
Patients and methods:
This is a comparative study , performed on patients aged ≤ 12 years and required surgery for glaucoma following congenital cataract surgery (GFCS) with or without intraocular lens (IOL) implantation. The study will be conducted at the outpatient clinic of Mansoura Ophthalmic Center of Mansoura University in Mansoura, Egypt.
Eyes in which the trabeculotomy involves <180° of Schlemm's canal ,eyes that have synechial angle closure over ≥ 90° and eyes that have previous procedures other than lensectomy or IOL implantation are excluded from the study. Eyes are then randomized to undergo single-site VT or two-site VT using a random table. The two-site VT by the rigid probe trabeculotome is performed through a superonasal and an inferotemporal triangular scleral flap. The primary outcome of this study is compare the success rate in lowering IOP between the 2 surgical options; the single-site VT versus two-site VT. Success is defined as IOP between 6-20 mmHg or 35% IOP reduction with or without topical anti-glaucoma medications and without visually-devastating complications or additional glaucoma surgery.
The secondary clinical outcomes will include Intraocular pressure (IOP) control values, horizontal corneal diameter, axial length, cup- disc ratio, antiglaucoma medication, refractive error and postoperative complications in these 2 surgical procedures. Data will be analysed.
Statistical analysis:
All statistical analysis was accomplished using IBM SPSS version 20. Assessment of the data normality was done using both Histogram plot and Shapiro-Wilk's test. Wilcoxon test was used to compare the preoperative and postoperative variables in each group. The comparison between the two groups was done using Mann-Whitney test for numerical variables and Chi-square test for categorical variables. Kaplan-Meier survival curve was plotted to estimate the mean survival time and probabilities of failure at different follow-up stages in the both groups. For all tests, P value of less than 0.05 was considered significant.
- Conditions
- Glaucoma Congenital
- Being tested
- single-site rigid probe viscotrabeculotomy (VT), two-site rigid probe viscotrabeculotomy (VT)
- Keywords
- Pediatric glaucoma,, Trabeculotomy, Congenital cataract surgery
- Medical subject headings
- Hydrophthalmos
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
single-site rigid probe viscotrabeculotomy (VT)Procedure or surgery
single-site VT by the rigid probe trabeculotome is performed through a superonasal triangular scleral flap.
two-site rigid probe viscotrabeculotomy (VT)Procedure or surgery
Two-site VT by the rigid probe trabeculotome is performed through a superonasal and an inferotemporal triangular scleral flap.
| Study group | Role | What they receive |
|---|---|---|
| single-site VT group | Active comparator | Viscotrabeculotomy is performed through a superonasal triangular scleral flap. Receives: Procedure: single-site rigid probe viscotrabeculotomy (VT) |
| two-site VT group | Active comparator | Viscotrabeculotomy is performed through a superonasal and an inferotemporal triangular scleral flap. Receives: Procedure: two-site rigid probe viscotrabeculotomy (VT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
the success rate in lowering IOP
Success is defined as IOP between 6-20 mmHg or 35% IOP reduction with or without topical anti-glaucoma medications and without visually-devastating complications or additional glaucoma surgery.
IOP was evaluted during each Follow up visit using applanation tonometry.
Measured: 3 years
Secondary outcomes (6)
Intraocular pressure (IOP) control values
measured at each follow up visit using tonopen ,icare or applantion tonometery
Measured: 3 years
antiglaucoma medications.
The total number of antiglaucoma medications needed to control the IOP
Measured: 3 years
postoperative complications
Include: Hyphaema with its grades, IOP spikes and Hypotony and possible inflammation or infections
Measured: 3 years
horizontal corneal diameter.
Measured manually during follow visits using a caliber
Measured: 3 years
axial length.
Measured by A scan mode of the US
Measured: 3 yeras
cup- disc ratio.
Detected clinically and documented by fundus photo
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2021
- Study startSep 2021 (estimated)
- Primary completionSep 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glaucoma CongenitalStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amr Mohammed Elsayed Abdelkader, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05011747
- Sponsor's protocol ID
- Viscotrabeculotomy in GFCS
- Status last verified
- Aug 2021
- First submitted
- 6 Aug 2021
- Last updated
- 18 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD will be provided as a supplementary digital content
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Surgical Outcomes of Viscotrabeculotomy in Pediatric Glaucoma Following Cataract Surgery
- ClinicalTrials.gov ID
- NCT05011747
- Acronym / sponsor ID
- Viscotrabeculotomy in GFCS
- Conditions
- Glaucoma Congenital
- Keywords
- Pediatric glaucoma,, Trabeculotomy, Congenital cataract surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- Sep 2021 (estimated)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 18 Aug 2021 (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.
Long term Surgical Outcomes of Viscotrabeculotomy in Pediatric Glaucoma Following Cataract Surgery.
Purpose:
This study aims to compare outcomes of single-site rigid probe viscotrabeculotomy (VT) to two-site VT in pediatric secondary glaucoma following cataract surgery.
Methods:
This is a comparative study was performed on patients aged ≤ 12 years and required surgery for glaucoma following congenital cataract surgery (GFCS) with or without intraocular lens (IOL) implantation. Eyes in which the trabeculotomy involves <180° of Schlemm's canal ,eyes that have synechial angle closure over ≥ 90° and eyes that have previous procedures other than lensectomy or IOL implantation are excluded from the study. Eyes are then randomized to undergo single-site VT or two-site VT using a random table. The two-site VT by the rigid probe trabeculotome is performed through a superonasal and an inferotemporal triangular scleral flap. Intraocular pressure (IOP), anti-glaucoma medications, complications and success rates at dates of follow up are all reported. Success is defined as IOP between 6-20 mmHg or 35% IOP reduction with or without topical anti-glaucoma medications and without visually-devastating complications or additional glaucoma surgery.
Detailed description
Long term Surgical Outcomes of Viscotrabeculotomy in Pediatric Glaucoma Following Cataract Surgery.
Introduction:
Despite advances in congenital cataract management, secondary glaucoma (SG) remains a major postoperative sight-threatening complication, with open-angle glaucoma being the predominant type in both aphakic and pseudophakic children . Although the pathogenesis of glaucoma after cataract surgery remains unclear, several risk factors have been identified. These include early surgery, chronic postoperative inflammation , primary posterior capsulotomy , persistence of fetal vasculature , and microphthalmia .
However, the pathogenesis of the classic, open-angle type of glaucoma that develops on average 1.3-12.2 years following uneventful cataract surgery is still obscure. Mechanical collapse of the trabecular meshwork due to the loss of ciliary body tension could be one of the possible reasons. Some speculate that obstruction of the trabecular meshwork by inflammatory cells, lens remnants and vitreous-derived factors may result in delayed elevation in IOP. Arrest of postnatal angle maturation secondary to the surgical intervention could be a contributing factor, especially that aphakic glaucoma is more likely to occur in patients who had lensectomy at a younger age, usually the first year of life. The incidence of secondary pediatric glaucoma after cataract surgery is not yet precisely identified. It ranges from 3%-41% depending on the follow-up period and the criteria chosen to define glaucoma . Management of paediatric glaucoma following cataract surgery (GFCS) is challenging. Trabeculectomy has a poor success rate and precludes the use of contact lenses, especially in the presence of thin, avascular, cystic blebs . Glaucoma drainage devices have a higher chance of success than trabeculectomy, but aphakic eyes have relatively higher rates of complications, especially suprachoroidal haemorrhage, if hypotony occurs particularly if buphthalmic. GDD-implanted eyes also carry a life-long risk of developing keratopathy secondary to endothelial decompensation from the tube end .Cyclodestructive procedures provide a temporizing treatment with occasional longterm control after multiple treatments. Yet, it is difficult to titrate with marked inflammation and a risk of phthisis, especially in microphthalmic eyes. Furthermore, it may be associated with chronic hypotony and may prejudice future surgery to failure. Angle surgery was first described as a surgical option in GFCS by Chen et al., yielding promising results in terms of IOP lowering and surgical success. Unlike bleb-based procedures, angle surgery addresses the more physiological outflow pathway through the trabecular meshwork and Schlemm's canal. Hence the risk of bleb-based complications such as infection, bleb leak, overfiltration and bleb dysthesia is reduced. With the growing evidence that circumferential trabeculotomy yields superior results to conventional 180° angle surgery in primary congenital glaucoma16, Freedman et al. retrospectively reported the results of microcatheter-assisted circumferential trabeculotomy in GFCS, achieving a 72% success rate. several reports in treatment of pediatric glaucoma have concluded that the use of viscoelastic materials during trabeculotomy may increase the success rate of the procedure by preventing ocular decompression, postoperative hemorrhage, anterior chamber shallowness, and adhesion of the incision lips or fibroblastic proliferation18.The purpose of the present study was to compare outcomes of single-site rigid probe viscotrabeculotomy (VT) Versus two-site VT in pediatric secondary glaucoma following cataract surgery.
Patients and methods:
This is a comparative study , performed on patients aged ≤ 12 years and required surgery for glaucoma following congenital cataract surgery (GFCS) with or without intraocular lens (IOL) implantation. The study will be conducted at the outpatient clinic of Mansoura Ophthalmic Center of Mansoura University in Mansoura, Egypt.
Eyes in which the trabeculotomy involves <180° of Schlemm's canal ,eyes that have synechial angle closure over ≥ 90° and eyes that have previous procedures other than lensectomy or IOL implantation are excluded from the study. Eyes are then randomized to undergo single-site VT or two-site VT using a random table. The two-site VT by the rigid probe trabeculotome is performed through a superonasal and an inferotemporal triangular scleral flap. The primary outcome of this study is compare the success rate in lowering IOP between the 2 surgical options; the single-site VT versus two-site VT. Success is defined as IOP between 6-20 mmHg or 35% IOP reduction with or without topical anti-glaucoma medications and without visually-devastating complications or additional glaucoma surgery.
The secondary clinical outcomes will include Intraocular pressure (IOP) control values, horizontal corneal diameter, axial length, cup- disc ratio, antiglaucoma medication, refractive error and postoperative complications in these 2 surgical procedures. Data will be analysed.
Statistical analysis:
All statistical analysis was accomplished using IBM SPSS version 20. Assessment of the data normality was done using both Histogram plot and Shapiro-Wilk's test. Wilcoxon test was used to compare the preoperative and postoperative variables in each group. The comparison between the two groups was done using Mann-Whitney test for numerical variables and Chi-square test for categorical variables. Kaplan-Meier survival curve was plotted to estimate the mean survival time and probabilities of failure at different follow-up stages in the both groups. For all tests, P value of less than 0.05 was considered significant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| single-site VT group | Active comparator | Procedure: single-site rigid probe viscotrabeculotomy (VT)Viscotrabeculotomy is performed through a superonasal triangular scleral flap. |
| two-site VT group | Active comparator | Procedure: two-site rigid probe viscotrabeculotomy (VT)Viscotrabeculotomy is performed through a superonasal and an inferotemporal triangular scleral flap. |
Who may qualify
- Ages
- 2 months to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- -Patients aged ≤ 12 years and required surgery for glaucoma following congenital cataract surgery (GFCS) with or without intraocular lens (IOL) implantation.
Key exclusion criteria (3 listed)
- Eyes in which the trabeculotomy involves <180° of Schlemm's canal.
- Eyes that have synechial angle closure over ≥ 90°.
- Eyes that have previous procedures other than lensectomy or IOL implantation.
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 |
|---|---|---|
| single-site rigid probe viscotrabeculotomy (VT)single-site VT by the rigid probe trabeculotome is performed through a superonasal triangular scleral flap. | Procedure or surgery | single-site VT group |
| two-site rigid probe viscotrabeculotomy (VT)Two-site VT by the rigid probe trabeculotome is performed through a superonasal and an inferotemporal triangular scleral flap. | Procedure or surgery | two-site VT group |
Primary outcome
the success rate in lowering IOP
Time frame: 3 years
Success is defined as IOP between 6-20 mmHg or 35% IOP reduction with or without topical anti-glaucoma medications and without visually-devastating complications or additional glaucoma surgery. IOP was evaluted during each Follow up visit using applanation tonometry.
6 secondary outcomes
Intraocular pressure (IOP) control values
Time frame: 3 years
antiglaucoma medications.
Time frame: 3 years
postoperative complications
Time frame: 3 years
horizontal corneal diameter.
Time frame: 3 years
axial length.
Time frame: 3 yeras
cup- disc ratio.
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2021.
- Individual participant dataSharing planned: Yes. IPD will be provided as a supplementary digital content
Related trials for Glaucoma Congenital
RecruitingPhase 1/2
GVB-2001 Gene Therapy Via Intracameral Injection for the Treatment of Primary Open Angle Glaucoma
Primary Open-Angle Glaucoma (POAG)
Not yet recruitingObservational study
Goniotomy in Primary Congenital Glaucoma
Primary Congenital Glaucoma, Goniotomy
Not yet recruiting
Study Aim to Compare the Effect of Different Technique of Airway Managment During Anaesthesia on the Haemodynamics and Intraocular Pressure. Patients Were Divided Into Three Groups of 25 Patients Each. (Group A); Patients Who Were Subjected to LMA Insertion (Group B ).
Congenital Glaucoma
Active, not recruiting
Inverted T Trabeculectomy Primary Congenital Glaucoma
Glaucoma, Congenital, Surgical Treatment
Active, not recruitingObservational study
Glaucoma Following Pediatric Cataract Surgery
Glaucoma Following Pediatric Cataract Surgery, Glaucoma Secondary
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.
Questions about this trial
What is this clinical trial studying?
A study testing single-site rigid probe viscotrabeculotomy (VT) and two-site rigid probe viscotrabeculotomy (VT) in people with Glaucoma Congenital, run by Mansoura University.
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 1 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 18 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amr Mohammed Elsayed A Mohammed, MD, FRCS (01004314242 ext. +20, dramrabdelkader@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the success rate in lowering IOP (time frame: 3 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 18 Aug 2021; AzTrials last refreshed its copy on 6 Nov 2026.