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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

Tracking Information
First Submitted Date  ICMJE December 24, 2015
First Posted Date  ICMJE January 13, 2016
Last Update Posted Date January 13, 2016
Study Start Date  ICMJE September 2014
Estimated Primary Completion Date April 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 12, 2016)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: January 12, 2016)
  • Anti-glaucoma drug number [ Time Frame: 1, 3, 6 ,9 and 12 month ]
  • Visual acuity [ Time Frame: 1, 3, 6 ,9 and 12 month ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Triamcinolone for Ahmed Glaucoma Valve
Official Title  ICMJE Adjunctive Triamcinolone Acetonide for Ahmed Glaucoma Valve Implantation
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Glaucoma
Intervention  ICMJE Drug: Adjunctival Triamcinolone
Intraoperative Periplate 10 mg Triamcinolone Injection during AGV Implantation
Other Name: Intraoperative steroid
Study Arms  ICMJE
  • 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
    Intervention: Drug: Adjunctival Triamcinolone
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: January 12, 2016)
106
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2016
Estimated Primary Completion Date April 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Iran, Islamic Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02653963
Other Study ID Numbers  ICMJE ShaheedBMU-9467
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Azadeh Doozandeh, Shahid Beheshti University of Medical Sciences
Study Sponsor  ICMJE Shahid Beheshti University of Medical Sciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Azadeh Doozandeh, MD Ophthalmology research center, Shahid Beheshti University Of Medical Sciences
PRS Account Shahid Beheshti University of Medical Sciences
Verification Date January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP