Express Implant Versus Trabeculectomy After Late Failure Trabeculectomy

Menoufia University

Status: Completed

Conditions: Glaucoma

Treatments: Procedure: Express implant device

Study type: Interventional

Funder types: Other

Identifiers

NCT04417920

late failure trabeculectomy

Details and patient eligibility

About

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

Full 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.

Enrollment: 28 patients

Sex: All

Ages: 42 to 55 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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28 participants in 2 patient groups

group I (Express implant)

Active Comparator group

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

Treatment:

Procedure: Express implant device

group II (trabeculectomy)

Active Comparator group

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

Treatment:

Procedure: Express implant device