Express Implant Versus Trabeculectomy After Late Failure Trabeculectomy

June 4, 2020 updated by: Ahmed Alnagdy, Menoufia University

Express Implant Versus Trabeculectomy in a Fibrotic Bleb With Late Failure After Previous Trabeculectomy

To compare between outcome of Express implant and subscleral trabeculectomy (SST) in management of glaucoma after previous trabeculectomy with a fibrotic bleb.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • AlDakahlia
      • Mansoura, AlDakahlia, Egypt, 35511
        • Tharwat Mokbel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

42 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: group I (Express implant)
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

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.

Other Names:
  • Trabeculectomy with Mitomycin-C
Active Comparator: group II (trabeculectomy)

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

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.

Other Names:
  • Trabeculectomy with Mitomycin-C

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change of intra ocular pressure (IOP)
Time Frame: one year follow up

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

one year follow up

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Faried Wagdy, Prof., Gamal Abd El Nasr st. - Shebin ElKoum - Menofia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2017

Primary Completion (Actual)

May 1, 2019

Study Completion (Actual)

May 20, 2020

Study Registration Dates

First Submitted

May 21, 2020

First Submitted That Met QC Criteria

June 4, 2020

First Posted (Actual)

June 5, 2020

Study Record Updates

Last Update Posted (Actual)

June 5, 2020

Last Update Submitted That Met QC Criteria

June 4, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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