Express Implant Versus Trabeculectomy After Late Failure Trabeculectomy

NCT ID: NCT04417920

Last Updated: 2020-06-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-01
• Study Completion Date: 2020-05-20

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.

Conditions

Glaucoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

Express implant device

Intervention Type: 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.

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

Group Type: ACTIVE_COMPARATOR

Express implant device

Intervention Type: 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.

Interventions

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.

Intervention Type: PROCEDURE

Other Intervention Names

Trabeculectomy with Mitomycin-C

Eligibility Criteria

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

• Minimum Eligible Age: 42 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Menoufia University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Alnagdy

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Faried Wagdy, Prof.

Role: STUDY_CHAIR

Gamal Abd El Nasr st. - Shebin ElKoum - Menofia

Locations

Tharwat Mokbel

Al Mansurah, AlDakahlia, Egypt

Countries

Egypt

References

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.

Reference Type: DERIVED

PMID: 36912740 (View on PubMed)

Other Identifiers

late failure trabeculectomy

Identifier Type: -

Identifier Source: org_study_id