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Pars Plana Ex-Press Shunt in Vitrectomized Eyes

Primary Purpose

Glaucoma Secondary

Status
Unknown status
Phase
Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
Express Mini shunt
Sponsored by
Cairo University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glaucoma Secondary focused on measuring Express Mini shunt; Pars plana; Vitrectomized eye

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Secondary Glaucoma after vitrectomy not responding to maximum medical treatment

Exclusion Criteria:

  • Phakic eyes
  • Siliconized eyes
  • History of Uveitis

Sites / Locations

  • Cairo UniversityRecruiting

Outcomes

Primary Outcome Measures

Intraocular pressure control (IOP)
IOP less than 18 mmHg

Secondary Outcome Measures

Full Information

First Posted
July 23, 2018
Last Updated
April 18, 2019
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT03605823
Brief Title
Pars Plana Ex-Press Shunt in Vitrectomized Eyes
Official Title
Pars Plana Ex-Press Mini Shunt for Management of Persistent Glaucoma in Vitrectomized Eye. A Potential Novel Technique.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
November 1, 2017 (Actual)
Primary Completion Date
November 1, 2019 (Anticipated)
Study Completion Date
November 1, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma Secondary
Keywords
Express Mini shunt; Pars plana; Vitrectomized eye

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Express Mini shunt
Intervention Description
Implantation of Express Mini shunt through pars plana in vitrectomized eyes
Primary Outcome Measure Information:
Title
Intraocular pressure control (IOP)
Description
IOP less than 18 mmHg
Time Frame
6 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Secondary Glaucoma after vitrectomy not responding to maximum medical treatment Exclusion Criteria: Phakic eyes Siliconized eyes History of Uveitis
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Abdussalam M Abdullatif, MD
Phone
201117039868
Ext
20
Email
abdussalamabdullatif@kasralainy.edu.eg
Facility Information:
Facility Name
Cairo University
City
Cairo
ZIP/Postal Code
11956
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tamer A Macky, MD
Phone
201227892888
Ext
20
Email
tamermacky@gmail.com
First Name & Middle Initial & Last Name & Degree
Heba M ElSaied, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Pars Plana Ex-Press Shunt in Vitrectomized Eyes

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