Narrow-Angle GlaucomaNCT06120621
Combined VCST With Phacoemulsification Versus Phacoemulsification in Primary Angle Closure Glaucoma
A study testing Arm 1 : VCST-phaco group , Arm 2 : phaco group. in people with Narrow-Angle Glaucoma, run by Mansoura University at 1 site in Egypt.
Trial summary
As ab externo metal probe trabeculotomy cannot achieve 360-degree circumferential angle surgery, prolene suture can be used to achieve this without the need for an illuminated microcatheter. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Narrow-Angle Glaucoma
- What is being tested?
- Arm 1 : VCST-phaco group , Arm 2 : phaco group.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2023to 1 Oct 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- PACG
- patent iridotomy,
- synechial angle closure of more than 180 degrees that occluded the trabecular meshwork as confirmed by indentation gonioscopy
- an IOP greater than 21 mm Hg despite maximally tolerated antiglaucoma medications -no history of intraocular surgery other than laser iridotomy. -
Who cannot join
- Patients with primary open-angle glaucoma
- secondary glaucomas
- patients on anticoagulant therapy and cannot stop treatment
- patients with media opacity that interfere with cataract surgery, visual field testing, or OCT imaging
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Combined Visco-Circumferential-Suture-Trabeculotomy With Phacoemulsification Versus Phacoemulsification in Primary Angle Closure Glaucoma: A 2-Year Randomized Controlled Trial.
As ab externo metal probe trabeculotomy cannot achieve 360-degree circumferential angle surgery, prolene suture can be used to achieve this without the need for an illuminated microcatheter. In order to combine the advantages of the use of viscoelastic and those of circumferential trabeculotomy, this technique (Visco-Circumferential-Suture- Trabeculotomy "VCST") was previously used successfully in PCG. In the current study , the authors hypothesize that combination of VCST with phacoemulsification in primary angle closure glaucoma patients may have an added affect to phacoemulsification alone in cases with more extent of angle damage and that the injection of a viscoelastic into both ends of the unroofed SC before its cannulation by a polypropylene suture and subsequent circumferential trabeculotomy may facilitate circumferential cannulation of SC and hence the trabeculotomy and increase the success of the technique
Read the detailed description
Aim of the work: To assess the surgical outcomes of Combined Visco-Circumferential-Suture-Trabeculotomy with Phacoemulsification compared to phacoemulsification alone in the management of chronic primary angle closure glaucoma (CPACG).
Patients \& Methods:
This is a prospective randomized controlled clinical trial including eyes with uncontrolled CPACG and indicated for surgery. The study will be held in Mansoura ophthalmic center in the duration from September 2023 and March 2024. Patients will be randomized to undergo either Visco-Circumferential-Suture-Trabeculotomy followed by Phacoemulsification (VCST-phaco group) or phacoemulsification alone (phaco group). Randomization will be done through closed envelope method.
Sample size was calculated using website, http://www.raosoft.com/samplesize.html Values for prevalence of primary angle closure glaucoma were used to calculate the study population from Cheng et al. 50 cases will be included in the study, 25 for each group Patients will be included in the study if they have (1) PACG (2) a patent iridotomy, (3) synechial angle closure of more than 180 degrees that occluded the trabecular meshwork as confirmed by indentation gonioscopy, (4) an IOP greater than 21 mm Hg despite maximally tolerated antiglaucoma medications, and (5) no history of intraocular surgery other than laser iridotomy. Primary ACG is defined by the presence of elevated IOP (>21 mm Hg) and synechial angle closure of a gonioscopically narrow angle with optic nerve cupping typical of glaucoma and corresponding matching visual field defects. Patients with an acute attack or a known recent chronic ACG attack will be excluded from the study. Patients with primary open-angle glaucoma and secondary glaucomas who are on anticoagulant therapy and cannot stop treatment or with media opacity that interfere with cataract surgery, visual field testing, or OCT imaging will be excluded from the study.
In all patients, a thorough history will be taken then a full ophthalmological examination will be done, particularly estimation of the best corrected visual acuity (BCVA) using the decimal notation, slit lamp examination, and IOP measurement by Goldmann's applanation tonometry. Gonioscopy using Goldmann 3-mirrors goniolens for angle grading using Schaffer's grading system and fundus examination. Visual field (VF) assessment will be performed by SITA strategy perimetry (Humphrey, central 24-2 standard strategy). Retinal nerve fiber layer (RNFL) thickness and optic nerve head will be evaluated using a spectral domain optical coherence tomography (OCT; Topcon, Japan). Ultrasound biometry will be performed, and the anterior chamber depth (ACD) will be recorded. The number of antiglaucoma medications is also recorded.
Postoperative follow up visits will be planned on the first day, first week, second week, at first month, three months and six months. Outcome measures include the IOP value at each visit, BCVA, the number of IOP lowering medications used, and occurrence of any complications. The criteria for complete success is defined as an intraocular pressure between 6 and 18 mmHg, with a reduction of at least 30% from the baseline IOP. This should be achieved without the use of IOP-lowering medications or further surgery and any vision-threatening complications. Qualified success is defined as the same criteria for complete success but with the use of IOP-lowering medications.
- Conditions
- Narrow-Angle Glaucoma
- Being tested
- Arm 1 : VCST-phaco group , Arm 2 : phaco group.
- Medical subject headings
- Glaucoma, Angle-Closure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arm 1 : VCST-phaco group , Arm 2 : phaco group.Procedure or surgery
Arm 1 : VCST-phaco group , Arm 2 : phaco group.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Active comparator | Visco-Circumferential-Suture-Trabeculotomy followed by Phacoemulsification Receives: Procedure: Arm 1 : VCST-phaco group , Arm 2 : phaco group. |
| Arm 2 | Active comparator | phacoemulsification alone Receives: Procedure: Arm 1 : VCST-phaco group , Arm 2 : phaco group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
IOP control
The criteria for complete success is defined as an intraocular pressure between 6 and 18 mmHg, with a reduction of at least 30% from the baseline IOP. This should be achieved without the use of IOP-lowering medications or further surgery and any vision-threatening complications. Qualified success is defined as the same criteria for complete success but with the use of IOP-lowering medications.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2023
- Study start1 Jan 2023
- Primary completion1 Sep 2023
- Study completion1 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Narrow-Angle GlaucomaStudies 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dina abdelfattah, Mansoura University
- Investigators
- Ahmed El wehidy, professor, Principal investigator, professor of ophthalmology, Mansoura university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06120621
- Sponsor's protocol ID
- R.23.10.2345.R1
- Status last verified
- Mar 2025
- First submitted
- 24 Oct 2023
- Last updated
- 5 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: results will be shared
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Visco-Circumferential-Suture-Trabeculotomy With Phacoemulsification Versus Phacoemulsification in Primary Angle Closure Glaucoma: A 2-Year Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT06120621
- Acronym / sponsor ID
- R.23.10.2345.R1
- Conditions
- Narrow-Angle Glaucoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 1 Oct 2023 (actual)
- First posted
- 7 Nov 2023 (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.
As ab externo metal probe trabeculotomy cannot achieve 360-degree circumferential angle surgery, prolene suture can be used to achieve this without the need for an illuminated microcatheter. In order to combine the advantages of the use of viscoelastic and those of circumferential trabeculotomy, this technique (Visco-Circumferential-Suture- Trabeculotomy "VCST") was previously used successfully in PCG. In the current study , the authors hypothesize that combination of VCST with phacoemulsification in primary angle closure glaucoma patients may have an added affect to phacoemulsification alone in cases with more extent of angle damage and that the injection of a viscoelastic into both ends of the unroofed SC before its cannulation by a polypropylene suture and subsequent circumferential trabeculotomy may facilitate circumferential cannulation of SC and hence the trabeculotomy and increase the success of the technique
Detailed description
Aim of the work: To assess the surgical outcomes of Combined Visco-Circumferential-Suture-Trabeculotomy with Phacoemulsification compared to phacoemulsification alone in the management of chronic primary angle closure glaucoma (CPACG).
Patients \& Methods:
This is a prospective randomized controlled clinical trial including eyes with uncontrolled CPACG and indicated for surgery. The study will be held in Mansoura ophthalmic center in the duration from September 2023 and March 2024. Patients will be randomized to undergo either Visco-Circumferential-Suture-Trabeculotomy followed by Phacoemulsification (VCST-phaco group) or phacoemulsification alone (phaco group). Randomization will be done through closed envelope method.
Sample size was calculated using website, http://www.raosoft.com/samplesize.html Values for prevalence of primary angle closure glaucoma were used to calculate the study population from Cheng et al. 50 cases will be included in the study, 25 for each group Patients will be included in the study if they have (1) PACG (2) a patent iridotomy, (3) synechial angle closure of more than 180 degrees that occluded the trabecular meshwork as confirmed by indentation gonioscopy, (4) an IOP greater than 21 mm Hg despite maximally tolerated antiglaucoma medications, and (5) no history of intraocular surgery other than laser iridotomy. Primary ACG is defined by the presence of elevated IOP (>21 mm Hg) and synechial angle closure of a gonioscopically narrow angle with optic nerve cupping typical of glaucoma and corresponding matching visual field defects. Patients with an acute attack or a known recent chronic ACG attack will be excluded from the study. Patients with primary open-angle glaucoma and secondary glaucomas who are on anticoagulant therapy and cannot stop treatment or with media opacity that interfere with cataract surgery, visual field testing, or OCT imaging will be excluded from the study.
In all patients, a thorough history will be taken then a full ophthalmological examination will be done, particularly estimation of the best corrected visual acuity (BCVA) using the decimal notation, slit lamp examination, and IOP measurement by Goldmann's applanation tonometry. Gonioscopy using Goldmann 3-mirrors goniolens for angle grading using Schaffer's grading system and fundus examination. Visual field (VF) assessment will be performed by SITA strategy perimetry (Humphrey, central 24-2 standard strategy). Retinal nerve fiber layer (RNFL) thickness and optic nerve head will be evaluated using a spectral domain optical coherence tomography (OCT; Topcon, Japan). Ultrasound biometry will be performed, and the anterior chamber depth (ACD) will be recorded. The number of antiglaucoma medications is also recorded.
Postoperative follow up visits will be planned on the first day, first week, second week, at first month, three months and six months. Outcome measures include the IOP value at each visit, BCVA, the number of IOP lowering medications used, and occurrence of any complications. The criteria for complete success is defined as an intraocular pressure between 6 and 18 mmHg, with a reduction of at least 30% from the baseline IOP. This should be achieved without the use of IOP-lowering medications or further surgery and any vision-threatening complications. Qualified success is defined as the same criteria for complete success but with the use of IOP-lowering medications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Active comparator | Procedure: Arm 1 : VCST-phaco group , Arm 2 : phaco group.Visco-Circumferential-Suture-Trabeculotomy followed by Phacoemulsification |
| Arm 2 | Active comparator | Procedure: Arm 1 : VCST-phaco group , Arm 2 : phaco group.phacoemulsification alone |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- PACG
- patent iridotomy,
- synechial angle closure of more than 180 degrees that occluded the trabecular meshwork as confirmed by indentation gonioscopy
- an IOP greater than 21 mm Hg despite maximally tolerated antiglaucoma medications -no history of intraocular surgery other than laser iridotomy. -
Key exclusion criteria (4 listed)
- Patients with primary open-angle glaucoma
- secondary glaucomas
- patients on anticoagulant therapy and cannot stop treatment
- patients with media opacity that interfere with cataract surgery, visual field testing, or OCT imaging
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 |
|---|---|---|
| Arm 1 : VCST-phaco group , Arm 2 : phaco group.Arm 1 : VCST-phaco group , Arm 2 : phaco group. | Procedure or surgery | Arm 1, Arm 2 |
Primary outcome
IOP control
Time frame: one year
The criteria for complete success is defined as an intraocular pressure between 6 and 18 mmHg, with a reduction of at least 30% from the baseline IOP. This should be achieved without the use of IOP-lowering medications or further surgery and any vision-threatening complications. Qualified success is defined as the same criteria for complete success but with the use of IOP-lowering medications.
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 5 Mar 2025.
- Individual participant dataSharing planned: No. results will be shared
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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.
Ahmed El wehidy, professor principal investigator
professor of ophthalmology, Mansoura 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 Arm 1 : VCST-phaco group , Arm 2 : phaco group. in people with Narrow-Angle Glaucoma, run by Mansoura University 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 4 inclusion and 4 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 5 Mar 2025. 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 control (time frame: one year). 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 5 Mar 2025.