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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.

Completed

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

Official record
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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.

Egypt1 site
  • Mansoura University

    Al Mansurah, Dakahlia Governorate, 35111

Other trials in Egypt

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.

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 groups in NCT06120621
Study groupRoleWhat they receive
Arm 1Active comparatorVisco-Circumferential-Suture-Trabeculotomy followed by Phacoemulsification
Receives: Procedure: Arm 1 : VCST-phaco group , Arm 2 : phaco group.
Arm 2Active comparatorphacoemulsification 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.

  1. 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.

  1. First posted7 Nov 2023
  2. Study start1 Jan 2023
  3. Primary completion1 Sep 2023
  4. Study completion1 Oct 2023

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
Masking
Single blind
Who is masked
Participant
Enrolment
50 participants (actual)
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

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.

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