Express Implant Versus Trabeculectomy After Late Failure Trabeculectomy

Glaucoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04417920
• Other study ID #: late failure trabeculectomy
• Status: Completed
• Phase: N/A
• Start date: July 1, 2017
• Est. completion date: May 20, 2020

Study information

• Verified date: June 2020
• Source: Menoufia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: May 20, 2020
• Est. primary completion date: May 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 42 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Glaucoma

Intervention

Procedure:
• Express implant device
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.

Locations

Country	Name	City	State
Egypt	Tharwat Mokbel	Mansoura	AlDakahlia

Sponsors (1)

Lead Sponsor	Collaborator
Menoufia University

Country where clinical trial is conducted

Egypt, 

Outcome

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