Express Implant Versus Trabeculectomy After Late Failure Trabeculectomy

NCT04417920 | Completed

• 1 other identifier: late failure trabeculectomy
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Glaucoma

Keywords

Express valve; Failed Trabeculectomy

Outcome Measures

Primary Outcomes (1)

• 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

  one year follow up

Secondary Outcomes (3)

• Visual acuity changes by Decimal

  one year follow up

• Glaucomatous visual field (VF) changes in median deviation by decibels (dB)

  one year follow up

• Changes in optic Cup-to-Disc ratio by Volk+90 non-contact lens

  one year follow up

Study Arms (2)

group I (Express implant)

ACTIVE COMPARATOR

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

Procedure: Express implant device

group II (trabeculectomy)

ACTIVE COMPARATOR

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

Procedure: Express implant device

Interventions

Express implant device PROCEDURE

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.

Also known as: Trabeculectomy with Mitomycin-C

group I (Express implant); group II (trabeculectomy)

Eligibility Criteria

• Age: 42 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Menoufia University: lead

Study Sites (1)

Tharwat Mokbel

Al Mansurah, AlDakahlia, 35511, Egypt

Location

Related Publications (1)

• Park J, Rittiphairoj T, Wang X, E JY, Bicket AK. Device-modified trabeculectomy for glaucoma. Cochrane Database Syst Rev. 2023 Mar 13;3(3):CD010472. doi: 10.1002/14651858.CD010472.pub3.

  PMID: 36912740 DERIVED

MeSH Terms

Conditions

Glaucoma

Interventions

Trabeculectomy; Mitomycin

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Intervention Hierarchy (Ancestors)

Filtering Surgery; Ophthalmologic Surgical Procedures; Surgical Procedures, Operative; Mitomycins; Indolequinones; Quinones; Organic Chemicals; Azirines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Faried Wagdy, Prof.

  Gamal Abd El Nasr st. - Shebin ElKoum - Menofia

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: May 21, 2020
• First Posted: June 5, 2020
• Study Start: July 1, 2017
• Primary Completion: May 1, 2019
• Study Completion: May 20, 2020
• Last Updated: June 5, 2020

Record last verified: 2020-06

Locations

EG (1)