Triamcinolone for Ahmed Glaucoma Valve

NCT ID: NCT02653963

Last Updated: 2022-06-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 106 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2016-12-31

Brief Summary

This triple-blind, stratified, randomized clinical trial includes 100 eyes of 100 patients aged 18 to 85 years with refractory glaucoma. Eligible subjects undergo stratified block randomization; eyes are first stratified to one of four subgroups: group 1:patients with previous failed trabeculectomy, group 2: uveitic glaucoma, group 3: neovascular glaucoma and group 4: other indications like aphakic glaucoma or glaucoma associated with vitreoretinal procedures.

In each subgroup, eyes are randomly assigned to the study arms using random blocks: conventional Ahmed Glaucoma Valve (AGV) implantation (group A, 50 eyes), Ahmed Glaucoma Valve (AGV) with intraoperative periplate triamcinolone injection (group B, 50 eyes).

Patients will be followed for one year. They will undergo full ophthalmology examination at first day, first week, month 1, 3, 6, 9 and 12 after the surgery.

The primary outcome measure is cumulative probability of success, defined as intraocular pressure (IOP) of 6-21 mm Hg, with or without medication, and no serious complications, additional glaucoma surgery, or loss of light perception.

The outcomes will be compared between two arms in each subgroup.

The number of eyes requiring medications, time to initiation of medications, and number of medications will be compared.

Detailed Description

All procedures was performed by glaucoma specialists under general anesthesia employing the same technique in all subjects. The surgical field was prepared and draped in the usual sterile fashion. After insertion of a lid speculum and irrigation with povidine iodine 5% solution, a 7-0 silk limbal traction suture was placed to rotate the globe and achieve optimal supratemporal exposure. A limbus-based conjunctival peritomy was created 4mm posterior to the limbus and Tenon's capsule was dissected using Westcott and Stevens scissors. Hemostasis was achieved using wet field bipolar cautery. The Ahmed Glaucoma Valve (AGV) plate was secured to the sclera 8 mm posterior to the limbus with two interrupted 7-0 silk sutures. The tube was trimmed to an appropriate length with the bevel facing anteriorly and inserted into the anterior chamber through a corneoscleral track created with a 23-gauge needle. The tube was fixed to the episclera with a 10-0 nylon mattress suture. A quadrangular donor scleral patch graft (4×7 mm) was fashioned to cover the exposed part of the tube and was secured to the sclera using 10-0 nylon sutures. At this stage, in adjunctive triamcinolone group, 10 mg triamcinolone was injected in the subtenon space around the Ahmed Glaucoma Valve (AGV) plate. The conjunctiva and Tenon were closed using 10-0 nylon suture in a running fashion. At the end of the procedure, a subconjunctival injection of 4 mg betamethasone and 50 mg cephazolin were given in all eyes.

All patients were examined on the first post-operative day; the postoperative regimen included topical chloramphenicol 0.5% eye drops 4 times per day for 1 week and topical betamethasone 0.1% eye drops 6 times per day which was tapered over 6 to 8 weeks, except in cases with severe inflammation which required a longer period of treatment.

Follow up examination was repeated every week during the first month and thereafter at 6 weeks, and 3, 6, 9 and 12 months after the operation. Possible complications such as endophthalmitis, choroidal effusion or hemorr, wound leakage, hyphema, hypotony, malignant glaucoma, implant exposure, tube malposition, bleb encapsulation, and decreased best corrected visual acuity (BCVA) more than 2 lines were mentioned. IOP was measured by a calibrated Goldmann applanation tonometer (SN-9007, Haag-Streit, Koniz, Switzerland). All measurements were obtained by one masked examiner.

The main outcome measure of the study was intraocular pressure and number of anti-glaucoma medications. Complete success was defined as IOP between 6 and 21 without the use of any glaucoma medication. Partial success was defined as IOP between 6 and 21 with a maximum of 2 glaucoma drops. Overall success rate was the sum of complete and partial success rates. Failure was defined as IOP>21, IOP<21 with ≥3 medications, loss of vision, shunt extrusion and need for additional glaucoma surgery. Other outcome measures included best corrected visual acuity (BCVA), number of glaucoma medications, and complications.

Conditions

Glaucoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Conventional AGV

A limbus-based conjunctival peritomy was created 4mm posterior to the limbus and Tenon's capsule was dissected. The AGV Plate was secured to the sclera 8 mm posterior to the limbus. The tube was trimmed to an appropriate length and inserted into the anterior chamber through a corneoscleral track. The tube was fixed to the episclera with a 10-0 nylon mattress suture. A donor sclera was fashioned to cover the exposed part of the tube and was secured to the sclera using 10-0 nylon sutures. The conjunctiva and Tenon were closed using 10-0 nylon suture.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Triamcinolone adjuctival AGV

Subtenon Periplate 10 mg triamcinolone acetonide around the AGV plate after fixation of AGV Plate to the sclera

Group Type: EXPERIMENTAL

Adjunctival Triamcinolone

Intervention Type: DRUG

Intraoperative Periplate 10 mg Triamcinolone Injection during AGV Implantation

Interventions

Adjunctival Triamcinolone

Intraoperative Periplate 10 mg Triamcinolone Injection during AGV Implantation

Intervention Type: DRUG

Other Intervention Names

Intraoperative steroid

Eligibility Criteria

Inclusion Criteria

• Eligible subjects were patients aged 18-85 years with refractory glaucoma scheduled for AGV implantation.

Exclusion Criteria

• Patients for whom AGV was implanted in any location except superior-temporal quadrant were excluded.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shahid Beheshti University of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Azadeh Doozandeh

ShaheedBMU

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Azadeh Doozandeh, MD

Role: PRINCIPAL_INVESTIGATOR

Ophthalmology research center, Shahid Beheshti University Of Medical Sciences

Locations

Ophthalmic Research Center

Tehran, , Iran

Countries

Iran

Other Identifiers

ShaheedBMU-9467

Identifier Type: -

Identifier Source: org_study_id