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Glaucoma SecondaryPhase 1/2NCT03605823

Pars Plana Ex-Press Shunt in Vitrectomized Eyes

A Phase 1/2 study testing Express Mini shunt in people with Glaucoma Secondary, run by Cairo University at 1 site in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Implantation of Ex-Press Minishunt via the pars plana in treatment of secondary glaucoma in vitrectomized eyes achieves promising results avoiding complications of other surgical modalities. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Glaucoma Secondary
What is being tested?
Express Mini shunt
Type of treatment
Medical device
How many people
20 participants
Where
1 siteEgypt
Study dates
1 Nov 2017to 1 Nov 2019
Phase
Phase 1/2
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Secondary Glaucoma after vitrectomy not responding to maximum medical treatment

Who cannot join

  • Phakic eyes
  • Siliconized eyes
  • History of Uveitis

Trial locations and contacts

1 site in 1 country.

Egypt1 site, 1 recruiting
  • Cairo University

    Cairo, 11956

    Tamer A Macky, MD, 201227892888 ext. 20, tamermacky@gmail.com

    Heba M ElSaied, MD

    Recruiting

Other trials in Egypt

About this study

Official title: Pars Plana Ex-Press Mini Shunt for Management of Persistent Glaucoma in Vitrectomized Eye. A Potential Novel Technique.

Implantation of Ex-Press Minishunt via the pars plana in treatment of secondary glaucoma in vitrectomized eyes achieves promising results avoiding complications of other surgical modalities.

Read the detailed description

Ex-Press valve implantation was performed under peribulbar anesthesia (5 mL solution of 2% lidocaine and 2.5 mL of 0.5% bupivicaine [Marcaine]). A fornix-based conjunctival flap was dissected with a conjunctival incision made 2mm from the superior limbus and blunt dissection in the sub-Tenon space. Corneal tractional suture using 7-0 Vicryl was taken for proper exposure then gentle cautery was performed. A 4 × 3 mm × 2/3 the scleral thickness scleral flap was dissected at 11 o'clock centered on a point 3.5mm from limbus.

A cellulose microsponge soaked in 0.4 mg/mL Mitomycin-C solution was applied to the scleral flap, with the conjunctiva draped over the sponge for 3 minutes. The sponge was then removed and the area was washed with irrigating saline solution.

Using a pressure plate for globe fixation and as a measure, three 23G valved vitrectomy cannulae were inserted in the superonasal, superotemporal and inferotemporal quadrants. The superior peripheral retina was examined by indentation to ensure absence of any vitreous and more shaving is done at this area if residual vitreous was seen.

The scleral flap was lifted. With the infusion on, a 25-gauge needle was inserted in the scleral bed 3.5 mm from the limbus, through the pars plana into the vitreous cavity. The direction of insertion should be perpendicular to the scleral bed towards the mid-vitreous cavity. The needle was then removed. There must not be any lateral movement of the needle as this will cause aqueous to flow around the implant. The Ex-Press ® P50 shunt is preloaded on an injector and metal rod is fitted into the lumen of the shunt, attached to the end of the injector. The shunt was then placed through the ostium created with the needle. The angle of entry with the shunt was the same as the angle used to make the ostium. The shunt was rotated 90° so that it enters the eye with the spur facing the long axis of the entry point then it was inserted all the way into the wound followed by rotation to its final position once it is inside the eye so that the external backplate was flush with the scleral bed. The injector has an area on the shaft that was then depressed which retracts the metal rod in the lumen of the shunt. This allows the injector to be free from the lumen of the shunt.

After ensuring proper position of the shunt by examining it from inside the vitreous cavity with indentation, the two superior cannulae were removed and 7-0 Vicryl sutures were taken to ensure the water tightness of the sclerotomies.

The scleral flap was then sutured in place using two 10-0 nylon sutures with a spatulated needle. The tightness of the second suture was adjusted so that there was a good percolation with infusion pressure maintained at 15 mmHg in the vitrectomy machine settings. The last cannula together with the infusion was removed and the sclerotomy was sutured. IOP was adjusted to be between 10 mmHg and 20 mmHg. The conjunctiva was then meticulously closed with running 7-0 Vicryl suture in a watertight fashion. A fluorescein strip was used to make sure the wound was watertight.

During the six postoperative weeks, topical corticosteroids and antibiotics were administered four times a day.

Being tested
Express Mini shunt
Keywords
Express Mini shunt; Pars plana; Vitrectomized eye

What participants receive

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

  • Express Mini shuntDevice

    Implantation of Express Mini shunt through pars plana in vitrectomized eyes

What is being measured

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

  1. Intraocular pressure control (IOP)

    IOP less than 18 mmHg

    Measured: 6 month

Timeline

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

  1. First posted30 Jul 2018
  2. Study start1 Nov 2017
  3. Primary completion1 Nov 2019 (estimated)
  4. Study completion1 Nov 2019 (estimated)

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03605823
Sponsor's protocol ID
0123
Status last verified
Apr 2019
First submitted
23 Jul 2018
Last updated
19 Apr 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Express Mini shunt in people with Glaucoma Secondary, run by Cairo 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 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 19 Apr 2019. 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.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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 Abdussalam M Abdullatif, MD (201117039868 ext. 20, abdussalamabdullatif@kasralainy.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Intraocular pressure control (IOP) (time frame: 6 month). 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 19 Apr 2019.

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