Express Implant Versus Trabeculectomy After Late Failure Trabeculectomy

Not Applicable

Completed

• Conditions: Glaucoma

• Registration Number: NCT04417920
• Lead Sponsor: Menoufia University

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.

Study Timeline

• Study Start: 2017-07-01
• Primary Completion: 2019-05-01
• Study Completion: 2020-05-20
• Study First Submitted: 2020-05-21
• Status Verified: 2020-06
• Study First Submitted QC: 2020-06-04
• Last Update Submitted: 2020-06-04
• Study First Posted: 2020-06-05
• Last Update Posted: 2020-06-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
change of intra ocular pressure (IOP)	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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Tharwat Mokbel; 🇪🇬 Mansoura, AlDakahlia, Egypt