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GlaucomaNCT04508881

Intraluminal Stenting Versus External Ligation of Ahmed Glaucoma Valve

A study testing Ahmed Glaucoma Valve in people with Glaucoma, run by Menoufia 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

Objectives: To compare the intraluminal stenting and external ligation of Ahmed Glaucoma Valve (AGV) regarding refractory glaucoma management and postoperative hypotony prevention. Patients and Methods: This randomized clinical trial included 30 eyes of 25 patients (age range: 44-56 y) with refractory glaucoma. Read more about this study

Who is it for?
Ages 44 to 56 years
Conditions the study is for
Glaucoma
What is being tested?
Ahmed Glaucoma Valve
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1 participants
Where
1 siteEgypt
Study dates
12 Sep 2018to 13 Jan 2020
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 44 to 56 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 30 eyes of 25 patients (age range: 44-56 y) with refractory glaucoma

Who cannot join

  • other types of glaucoma

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Faried Wagdy

    Cairo, Menofia

Other trials in Egypt

About this study

Official title: To Compare the Intraluminal Stenting and External Ligation of Ahmed Glaucoma Valve (AGV) Regarding Refractory Glaucoma Management and Postoperative Hypotony Prevention.

Objectives: To compare the intraluminal stenting and external ligation of Ahmed Glaucoma Valve (AGV) regarding refractory glaucoma management and postoperative hypotony prevention.

Patients and Methods: This randomized clinical trial included 30 eyes of 25 patients (age range: 44-56 y) with refractory glaucoma. This study was conducted during the period from September 2018 to January 2020. The study included two groups, AGV with intraluminal stenting group (n=15) and AGV with external ligation group (n=15). Follow up continued to a year post operation. The primary outcome was Intraocular pressure (IOP) and its association with the number of postoperative glaucoma medications. IOP ≤ 21 mmHg without medications announced complete success while IOP ≤ 21 mmHg with medications indicated qualified success. IOP of <6 mmHg defined hypotony.

Key Words: Stenting- ligation- Ahmed valve- Hypotony

Read the detailed description

Introduction: Refractory glaucoma is a complicated type of glaucoma difficult to be treated. This type is characterized by high IOP with a high resistance to be reduced by traditional medical or surgical therapy. Shunt surgery improve trabeculectomy poor long term outcomes in refractory glaucoma.1 AGV, a shunt device, is used either from the start or after conventional procedures failure in refractory glaucoma. It helps the aqueous humour flow direct in the silicone tube.2 AGV is effective in reducing the postoperative hypotony commonly seen in non valved implants however the presence of persistent hypotony is still a problem after AGV.3 Persistent hypotony after AGV is caused by over-priming the tube and excessive manipulation of the valve housing that may damage the valve mechanism, the outflow of aqueous humour around the silicone tube immediately post-operatorive after the utilization of a 22 or 23G needle in creation of the sclerostomy and ciliary body function failure post-surgery in complicated eyes in which AGV is used. 4-5 closure of the tube by ligation or stenting may be needed when postoperative ocular hypotony occurs. 6 Enough and expected outflow control may not be induced by ligation of the tube at a focal area. 7 postoperative ocular hypotony could be managed effectively by Ab interno tube stenting. 8-10 Patients and Methods: Thirty eyes with refractory glaucoma were included in randomized controlled clinical trial. Patients aged from 44 to 56 years old. Despite of tolerated medication after previous trabeculectomy surgery, those patients had high intraocular pressure (IOP). Approval of institutional research board committee was taken. Two groups were studied; AGV with intraluminal stenting group (n=15 eyes) and AGV with external ligation group (n=15 eyes). Follow- up to one year after the surgery was done. The primary outcome was Intraocular pressure (IOP) and its association with the number of postoperative glaucoma medications. IOP ≤ 21 mmHg without medications announced complete success while IOP ≤ 21 mmHg with medications indicated qualified success. IOP of <6 mmHg defined hypotony. All patients preoperatively were subjected to IOP measurement using Goldman applanation tonometer, visual acuity assessment (VA) using Snellen E chart, visual field analysis (VF) by Humphrey visual field analyzer, Angle examination by goniolens, optic disc examination by Volk+90 lens, sit lamp examination for assessment of corneal clarity and any corneal touch with the tube and anterior chamber depth. All patients had peribulbar anaesthesia. Operative technique: in group I, incision of superior-temporal conjunctiva was carried out, appropriate cauterization and approximately at 10 mm posterior to the corneal limbus, the valve body plate was placed. Forceps was used to insert A 7-0 prolene thread into the tube lumen; the prolene 7-0 thread was cut with scissors making it along the tube length to remove it when needed. (Figure 2) In group II, the same as in group I but 8-0 vicryl was used to ligate the tube with the underlying sclera in addition to usage of two interrupted prolene 7-0 sutures applied 2mm apart over the tube itself to make partial occlusion and then entered into the anterior chamber. (Figure 3) Postoperative treatment with combined antibiotic and steroid eye drops every four hours in the first week followed by 2 weeks gradual tapering. IOP, VA, VF, optic disc examination by Volk+90 lens, slit lamp examination were the follow-up parameters. Failure was considered if the patient needed to implant removal, added glaucoma surgery, or developed phthisis bulbi.

Statistical analysis: Data were statistically analyzed by SPSS version 22(SPSS Inc., Chicago, IL, USA). Non-paired t test and Mann-Whitney were applied to quantitative variables. Fisher's exact test was applied to qualitative variables. Correlation was used to assess strength and direction of association. Less than 0.05 P value was set to be significant.

Data Availability Statement:The data used to support the findings of this study are included within the article.

Compliance with Ethical Standards Funding Statement: None Conflicts of Interest: The author declares that there he has no conflict of interest regarding the publication of this paper.

Ethical approval: All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

Informed consent: Informed consent was obtained from all individual participants included in the study.

Conditions
Glaucoma
Being tested
Ahmed Glaucoma Valve
Medical subject headings
Glaucoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ahmed Glaucoma ValveDevice

    To compare the prevalence of postoperative hypotony between the 2 arms

Study groups in NCT04508881
Study groupRoleWhat they receive
External ligationActive comparatorExternal ligation of the valve tube by vicryl sutures
Receives: Device: Ahmed Glaucoma Valve
intraluminal stentingActive comparatorstenting of the valve tube by prolene suture
Receives: Device: Ahmed Glaucoma Valve

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Postoperative hypotony

    by measuring intraocular poressure postoperatively by Goldmann Applanation tonometer

    Measured: 1 year

Secondary outcomes (2)
  1. postoperative hypertensive phase by Goldmann Applanation tonometer

    by studying the incidence of hypertensive phase postoperatively

    Measured: 1 year

  2. low Complications

    by slit lamp examination

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Aug 2020
  2. Study start12 Sep 2018
  3. Primary completion10 Jan 2020
  4. Study completion13 Jan 2020

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
Model description
: This randomized clinical trial included 30 eyes of 25 patients (age range: 44-56 y) with refractory glaucoma. This study was conducted during the period from September 2018 to January 2020. The study included two groups, AGV with intraluminal stenting group (n=15) and AGV with external ligation group (n=15). Follow up continued to a year post operation. The primary outcome was Intraocular pressure (IOP) and its association with the number of postoperative glaucoma medications. IOP ≤ 21 mmHg without medications announced complete success while IOP ≤ 21 mmHg with medications indicated qualified success. IOP of \<6 mmHg defined hypotony.
Masking
None (open label)
Enrolment
1 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04508881
Sponsor's protocol ID
Faried1976
Other IDs
Tharwat Mokbel
Status last verified
Aug 2020
First submitted
21 Jul 2020
Last updated
11 Aug 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Ahmed Glaucoma Valve in people with Glaucoma, run by Menoufia 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 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: finished, as of the sponsor's last update on 11 Aug 2020. 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?

Postoperative hypotony (time frame: 1 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 11 Aug 2020.

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