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Express Implant Versus Trabeculectomy After Late Failure Trabeculectomy

Primary Purpose

Glaucoma

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Express implant device
Sponsored by
Menoufia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glaucoma focused on measuring Express valve, Failed Trabeculectomy

Eligibility Criteria

42 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • elevated intraocular pressure (IOP) with fibrotic bleb despite previous SST since more than 4 months
  • follow up 12mo after the second surgery

Exclusion Criteria:

  • SST failure other than fibrotic bleb were also excluded
  • follow up less than 4mo after the first surgery, and those less than 12mo after the second surgery

Sites / Locations

  • Tharwat Mokbel

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

group I (Express implant)

group II (trabeculectomy)

Arm Description

conjunctival peritomy superior-temporally away from the site of the fibrotic bleb at 12 o'clock, placed on the episclera under the conjunctiva and Tenon's capsule for a contact time of 3 minutes, ,triangular scleral flap , scleral dissection forward to the clear cornea to allow exposure of scleral spur then creation of a pilot hole is fashioned using a sapphire blade (Alcon laboratories,USA) then Express shunt 3 mm long device and external diameter 400 microns was implanted followed by closure of scleral flap and conjunctiva

Trabeculectomy with Mitomycin-C was done in superior-temporal region away from the fibrotic bleb at 12 o, clock. conjunctival peritomy superior-temporally away from the site of the fibrotic bleb at 12 o'clock, placed on the episclera under the conjunctiva and Tenon's capsule for a contact time of 3 minutes, ,triangular scleral flap , scleral dissection forward to the clear cornea to allow exposure of scleral spur then creation of sclerectomy and peripheral iridectomy and closed scleral flab and conjunctiva by nylon 10/0 sutures

Outcomes

Primary Outcome Measures

change of intra ocular pressure (IOP)
IOP measured with Goldmann applanation tonometry: Complete success in IOP considered as IOP less than 20 mmHg without treatment and a qualified success in IOP considered as IOP less than 20 mmHg with medical treatment and a failure in IOP control considered if IOP more than or equal 20 mmHg after surgery

Secondary Outcome Measures

Visual acuity changes by Decimal
glaucoma changes follow up
Glaucomatous visual field (VF) changes in median deviation by decibels (dB)
glaucoma changes follow up
Changes in optic Cup-to-Disc ratio by Volk+90 non-contact lens
glaucoma changes follow up

Full Information

First Posted
May 21, 2020
Last Updated
June 4, 2020
Sponsor
Menoufia University
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1. Study Identification

Unique Protocol Identification Number
NCT04417920
Brief Title
Express Implant Versus Trabeculectomy After Late Failure Trabeculectomy
Official Title
Express Implant Versus Trabeculectomy in a Fibrotic Bleb With Late Failure After Previous Trabeculectomy
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
July 1, 2017 (Actual)
Primary Completion Date
May 1, 2019 (Actual)
Study Completion Date
May 20, 2020 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
To compare between outcome of Express implant and subscleral trabeculectomy (SST) in management of glaucoma after previous trabeculectomy with a fibrotic bleb.
Detailed Description
Trabeculectomy is the main glaucoma surgery. Despite the good decline in intraocular pressure (IOP) that occur rapidly after the procedure, there is still failure occurring due to progressive subconjunctival fibrosis, with associated increased IOP. If the bleb is revived by needling with adjunctive 5-fluorouracil (5FU) and mitomycin C (MMC) that used intraoperatively for the majority of these cases , the associated rise in IOP was controlled if the revision occured early within the first three months after surgery. But less success occurred if the bleb revision was delayed. If these interventions fail, alternative approaches include new augmented trabeculectomy or aqueous shunt implantation. Express shunt allows aqueous to pass from anterior chamber to subconjunctival space like trabeculectomy .Express shunt is a non valved shunt, It has an advantage of less traumatic, less complications, low diffuse bleb and high success rate.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma
Keywords
Express valve, Failed Trabeculectomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
group I (Express implant)
Arm Type
Active Comparator
Arm Description
conjunctival peritomy superior-temporally away from the site of the fibrotic bleb at 12 o'clock, placed on the episclera under the conjunctiva and Tenon's capsule for a contact time of 3 minutes, ,triangular scleral flap , scleral dissection forward to the clear cornea to allow exposure of scleral spur then creation of a pilot hole is fashioned using a sapphire blade (Alcon laboratories,USA) then Express shunt 3 mm long device and external diameter 400 microns was implanted followed by closure of scleral flap and conjunctiva
Arm Title
group II (trabeculectomy)
Arm Type
Active Comparator
Arm Description
Trabeculectomy with Mitomycin-C was done in superior-temporal region away from the fibrotic bleb at 12 o, clock. conjunctival peritomy superior-temporally away from the site of the fibrotic bleb at 12 o'clock, placed on the episclera under the conjunctiva and Tenon's capsule for a contact time of 3 minutes, ,triangular scleral flap , scleral dissection forward to the clear cornea to allow exposure of scleral spur then creation of sclerectomy and peripheral iridectomy and closed scleral flab and conjunctiva by nylon 10/0 sutures
Intervention Type
Procedure
Intervention Name(s)
Express implant device
Other Intervention Name(s)
Trabeculectomy with Mitomycin-C
Intervention Description
Operative technique in group I (Express implant) was as in group II (trabeculectomy) except with no sclerectomy or peripheral iridectomy , the steps included conjunctival peritomy superior-temporally away from the site of the fibrotic bleb at 12 o'clock, placed on the episclera under the conjunctiva and Tenon's capsule for a contact time of 3 minutes, ,triangular scleral flap , scleral dissection forward to the clear cornea to allow exposure of scleral spur then creation of a pilot hole is fashioned using a sapphire blade (Alcon laboratories,USA) then Express shunt 3 mm long device and external diameter 400 microns was implanted followed by closure of scleral flap and conjunctiva. While in group II, Trabeculectomy with Mitomycin-C was done in superior-temporal region away from the fibrotic bleb at 12 o, clock.
Primary Outcome Measure Information:
Title
change of intra ocular pressure (IOP)
Description
IOP measured with Goldmann applanation tonometry: Complete success in IOP considered as IOP less than 20 mmHg without treatment and a qualified success in IOP considered as IOP less than 20 mmHg with medical treatment and a failure in IOP control considered if IOP more than or equal 20 mmHg after surgery
Time Frame
one year follow up
Secondary Outcome Measure Information:
Title
Visual acuity changes by Decimal
Description
glaucoma changes follow up
Time Frame
one year follow up
Title
Glaucomatous visual field (VF) changes in median deviation by decibels (dB)
Description
glaucoma changes follow up
Time Frame
one year follow up
Title
Changes in optic Cup-to-Disc ratio by Volk+90 non-contact lens
Description
glaucoma changes follow up
Time Frame
one year follow up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
42 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: elevated intraocular pressure (IOP) with fibrotic bleb despite previous SST since more than 4 months follow up 12mo after the second surgery Exclusion Criteria: SST failure other than fibrotic bleb were also excluded follow up less than 4mo after the first surgery, and those less than 12mo after the second surgery
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Faried Wagdy, Prof.
Organizational Affiliation
Gamal Abd El Nasr st. - Shebin ElKoum - Menofia
Official's Role
Study Chair
Facility Information:
Facility Name
Tharwat Mokbel
City
Mansoura
State/Province
AlDakahlia
ZIP/Postal Code
35511
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Express Implant Versus Trabeculectomy After Late Failure Trabeculectomy

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