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Triamcinolone for Ahmed Glaucoma Valve

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ClinicalTrials.gov Identifier: NCT02653963
Recruitment Status : Unknown
Verified January 2016 by Azadeh Doozandeh, Shahid Beheshti University of Medical Sciences.
Recruitment status was:  Recruiting
First Posted : January 13, 2016
Last Update Posted : January 13, 2016
Sponsor:
Information provided by (Responsible Party):
Azadeh Doozandeh, Shahid Beheshti University of Medical Sciences

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.


Condition or disease Intervention/treatment Phase
Glaucoma Drug: Adjunctival Triamcinolone Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 106 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Adjunctive Triamcinolone Acetonide for Ahmed Glaucoma Valve Implantation
Study Start Date : September 2014
Estimated Primary Completion Date : April 2016
Estimated Study Completion Date : December 2016


Arm Intervention/treatment
No Intervention: 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.
Experimental: Triamcinolone adjuctival AGV
Subtenon Periplate 10 mg triamcinolone acetonide around the AGV plate after fixation of AGV Plate to the sclera
Drug: Adjunctival Triamcinolone
Intraoperative Periplate 10 mg Triamcinolone Injection during AGV Implantation
Other Name: Intraoperative steroid




Primary Outcome Measures :
  1. INTRAOCULAR PRESSURE [ Time Frame: 1, 3, 6 ,9 and 12 month ]
    Intraocular pressure (IOP) of 6-21 mm Hg, with or without medication, and no serious complication


Secondary Outcome Measures :
  1. Anti-glaucoma drug number [ Time Frame: 1, 3, 6 ,9 and 12 month ]
  2. Visual acuity [ Time Frame: 1, 3, 6 ,9 and 12 month ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Exclusion criteria was poor compliance for follow up, previous AGV implantation, concomitant procedures such as deep vitrectomy or cataract surgery, and any major intra- or postoperative complication which could affect the outcomes of surgery.
  • Patients for whom AGV was implanted in any location except superior-temporal quadrant were excluded.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02653963


Contacts
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Contact: Azadeh Doozandeh, MD +989123904966 Azadeh.Doozandeh@gmail.com

Locations
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Iran, Islamic Republic of
Ophthalmic Research Center Recruiting
Tehran, Iran, Islamic Republic of, 16666
Contact: Azadeh Doozandeh, MD    +989123904966    Azadeh.Doozandeh@gmail.com   
Sponsors and Collaborators
Shahid Beheshti University of Medical Sciences
Investigators
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Principal Investigator: Azadeh Doozandeh, MD Ophthalmology research center, Shahid Beheshti University Of Medical Sciences

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Responsible Party: Azadeh Doozandeh, ShaheedBMU, Shahid Beheshti University of Medical Sciences
ClinicalTrials.gov Identifier: NCT02653963     History of Changes
Other Study ID Numbers: ShaheedBMU-9467
First Posted: January 13, 2016    Key Record Dates
Last Update Posted: January 13, 2016
Last Verified: January 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Azadeh Doozandeh, Shahid Beheshti University of Medical Sciences:
Steroid, Triamcinolone, Ahmed Glaucoma valve
Additional relevant MeSH terms:
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Glaucoma
Ocular Hypertension
Eye Diseases
Triamcinolone
Triamcinolone Acetonide
Triamcinolone hexacetonide
Triamcinolone diacetate
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action