Primary Congenital GlaucomaNCT04709497
Surgery for Primary Congenital Glaucoma in Neonates
A study testing viscotrabeculotomy (VT), visco-circumferential-suture-trabeculotomy (VCST) . and combined VT-Trabeculectomy with MMC (VT-Trab). in people with Primary Congenital Glaucoma, run by Mansoura University.
Trial summary
The current study aimed to compare between the long-term surgical outcomes of 3 surgical options (viscotrabeculotomy (VT), visco-circumferential-suture-trabeculotomy (VCST) or combined VT-Trabeculectomy with MMC (VT-Trab) in treatment of infants with (Primary Congenital Glaucoma (PCG)) below 1 month of age. Read more about this study
- Who is it for?
- Ages 1 day to 30 days
- Conditions the study is for
- Primary Congenital Glaucoma
- What is being tested?
- viscotrabeculotomy (VT), visco-circumferential-suture-trabeculotomy (VCST) . and combined VT-Trabeculectomy with MMC (VT-Trab).
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2021to 1 Jul 2023
- 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 1 day to 30 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Primary Congenital Glaucoma in Neonates
Who cannot join
- secondary Congenital Glaucoma in Neonates. Congenital Glaucoma presented after 1 month of age.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Surgery for Primary Congenital Glaucoma in Neonates:Randomized Controlled Study.
The current study aimed to compare between the long-term surgical outcomes of 3 surgical options (viscotrabeculotomy (VT), visco-circumferential-suture-trabeculotomy (VCST) or combined VT-Trabeculectomy with MMC (VT-Trab) in treatment of infants with (Primary Congenital Glaucoma (PCG)) below 1 month of age.
Read the detailed description
This is a prospective, randomised controlled trial. We plan to recruit 60 infants with primary congenital glaucoma and younger than 1 month of age at the outpatient clinic of Mansoura Ophthalmic Center of Mansoura University in Mansoura, Egypt. Eyes will be randomly assigned to undergo one of 3 surgical interventions: viscotrabeculotomy (VT), visco-circumferential-suture-trabeculotomy (VCST) or combined VT-Trabeculectomy with MMC (VT-Trab).
The primary outcome of this study is compare the success rate in lowering IOP between the 3 surgical options in infants with Primary Congenital Glaucoma (PCG) below 1 month of age. The secondary clinical outcomes will include Intraocular pressure (IOP), horizontal corneal diameter, axial length, cup-disc ratio, refractive error and postoperative complications in these 3 surgical procedures. Data will be analysed. Complete success was defined as an IOP from 5 to 16 mmHg (under general anesthesia), without antiglaucoma drugs (AGD) or further surgical interventions, without progression of corneal diameter or disk cupping, and without serious visual complications. Qualified success was defined as fulfilling the same criteria but with the use of AGD.
- Conditions
- Primary Congenital Glaucoma
- Being tested
- viscotrabeculotomy (VT), visco-circumferential-suture-trabeculotomy (VCST) ., combined VT-Trabeculectomy with MMC (VT-Trab).
- Medical subject headings
- Hydrophthalmos
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
viscotrabeculotomy (VT)Procedure or surgery
viscotrabeculotomy (VT)
visco-circumferential-suture-trabeculotomy (VCST) .Procedure or surgery
visco-circumferential-suture-trabeculotomy (VCST)
combined VT-Trabeculectomy with MMC (VT-Trab).Procedure or surgery
combined VT-Trabeculectomy with MMC (VT-Trab).
| Study group | Role | What they receive |
|---|---|---|
| viscotrabeculotomy (VT)). | Active comparator | Not described Receives: Procedure: viscotrabeculotomy (VT) |
| visco-circumferential-suture-trabeculotomy (VCST) | Active comparator | Not described Receives: Procedure: visco-circumferential-suture-trabeculotomy (VCST) . |
| Combined VT-Trabeculectomy with MMC (VT-Trab). | Active comparator | Not described Receives: Procedure: combined VT-Trabeculectomy with MMC (VT-Trab). |
What is being measured
The primary outcome is the main question the study is designed to answer.
success rate in lowering intraocular pressure (IOP)
Complete success was defined as an IOP from 5 to 16 mmHg (under general anesthesia), without AGD or further surgical interventions, without progression of corneal diameter or disk cupping, and without serious visual complications. Qualified success was defined as fulfilling the same criteria but with the use of AGD.
Measured: 3 years
Secondary outcomes (4)
horizontal corneal diameter
The change in "white to white" corneal diameters in mm measured by caliber.
Measured: 3 years
axial length
The change in axial length in mm measured by ultrasonography.
Measured: 3 years
cup-disc ratio
The change in cup -disc ratio as measured by optical coherence tomography.
Measured: 3 years
refractive error
The change in refractive error as measured by autorefractometer..
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 posted14 Jan 2021
- Study start1 Mar 2021 (estimated)
- Primary completion1 Mar 2023 (estimated)
- Study completion1 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Congenital GlaucomaStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 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
- NCT04709497
- Sponsor's protocol ID
- Viscotrabeculotomy VI
- Status last verified
- Jan 2021
- First submitted
- 9 Jan 2021
- Last updated
- 14 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: providing data as supplemental digital content
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgery for Primary Congenital Glaucoma in Neonates:Randomized Controlled Study.
- ClinicalTrials.gov ID
- NCT04709497
- Acronym / sponsor ID
- Viscotrabeculotomy VI
- Conditions
- Primary Congenital Glaucoma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Mar 2021 (estimated)
- Primary completion
- 1 Mar 2023 (estimated)
- Study completion
- 1 Jul 2023 (estimated)
- First posted
- 14 Jan 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.
The current study aimed to compare between the long-term surgical outcomes of 3 surgical options (viscotrabeculotomy (VT), visco-circumferential-suture-trabeculotomy (VCST) or combined VT-Trabeculectomy with MMC (VT-Trab) in treatment of infants with (Primary Congenital Glaucoma (PCG)) below 1 month of age.
Detailed description
This is a prospective, randomised controlled trial. We plan to recruit 60 infants with primary congenital glaucoma and younger than 1 month of age at the outpatient clinic of Mansoura Ophthalmic Center of Mansoura University in Mansoura, Egypt. Eyes will be randomly assigned to undergo one of 3 surgical interventions: viscotrabeculotomy (VT), visco-circumferential-suture-trabeculotomy (VCST) or combined VT-Trabeculectomy with MMC (VT-Trab).
The primary outcome of this study is compare the success rate in lowering IOP between the 3 surgical options in infants with Primary Congenital Glaucoma (PCG) below 1 month of age. The secondary clinical outcomes will include Intraocular pressure (IOP), horizontal corneal diameter, axial length, cup-disc ratio, refractive error and postoperative complications in these 3 surgical procedures. Data will be analysed. Complete success was defined as an IOP from 5 to 16 mmHg (under general anesthesia), without antiglaucoma drugs (AGD) or further surgical interventions, without progression of corneal diameter or disk cupping, and without serious visual complications. Qualified success was defined as fulfilling the same criteria but with the use of AGD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| viscotrabeculotomy (VT)). | Active comparator | Procedure: viscotrabeculotomy (VT) |
| visco-circumferential-suture-trabeculotomy (VCST) | Active comparator | Procedure: visco-circumferential-suture-trabeculotomy (VCST) . |
| Combined VT-Trabeculectomy with MMC (VT-Trab). | Active comparator | Procedure: combined VT-Trabeculectomy with MMC (VT-Trab). |
Who may qualify
- Ages
- 1 day to 30 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Primary Congenital Glaucoma in Neonates
Key exclusion criteria (1 listed)
- secondary Congenital Glaucoma in Neonates. Congenital Glaucoma presented after 1 month of age.
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 |
|---|---|---|
| viscotrabeculotomy (VT)viscotrabeculotomy (VT) | Procedure or surgery | viscotrabeculotomy (VT)). |
| visco-circumferential-suture-trabeculotomy (VCST) .visco-circumferential-suture-trabeculotomy (VCST) | Procedure or surgery | visco-circumferential-suture-trabeculotomy (VCST) |
| combined VT-Trabeculectomy with MMC (VT-Trab).combined VT-Trabeculectomy with MMC (VT-Trab). | Procedure or surgery | Combined VT-Trabeculectomy with MMC (VT-Trab). |
Primary outcome
success rate in lowering intraocular pressure (IOP)
Time frame: 3 years
Complete success was defined as an IOP from 5 to 16 mmHg (under general anesthesia), without AGD or further surgical interventions, without progression of corneal diameter or disk cupping, and without serious visual complications. Qualified success was defined as fulfilling the same criteria but with the use of AGD.
4 secondary outcomes
horizontal corneal diameter
Time frame: 3 years
axial length
Time frame: 3 years
cup-disc ratio
Time frame: 3 years
refractive error
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 14 Jan 2021.
- Individual participant dataSharing planned: Yes. providing data as supplemental digital content
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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 viscotrabeculotomy (VT), visco-circumferential-suture-trabeculotomy (VCST) . and combined VT-Trabeculectomy with MMC (VT-Trab). in people with Primary Congenital Glaucoma, 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 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: status not confirmed, as of the sponsor's last update on 14 Jan 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 M Mohammed, MD (1004314242 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?
success rate in lowering intraocular pressure (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 14 Jan 2021.