Comparison of Effect of Postoperative Cyclosporine A 2% Ophthalmic Emulsion and Betamethasone Eye Drop on Surgical Success of Trabeculectomy Procedure

NCT02114073 | Completed Phase 2 DMC

• 2 other identifiers: MUMS-911251IRCT138706111154N1
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Glaucoma is one of the leading causes of blindness worldwide and trabeculectomy is the most commonly performed operation to slow-down the disease progression. In this study, we compare the effect of topical cyclosporine A and betamethasone eye drops on the postoperative course and surgical success of trabeculectomy.

Conditions

Glaucoma, Open Angle

Keywords

glaucoma; trabeculectomy; cyclosporine; betamethasone

Outcome Measures

Primary Outcomes (3)

• Intraocular Pressure (IOP)

  Each month following trabeculectomy, intraocular pressure will be measured using Goldmann Applanation Tonometer.

  Up to 6 months after surgery

• Bleb morphology

  Bleb morphology according to IBAGS grading system, based on clinical examination and slit-lamp photography.

  Up to 6 months after surgery

• Subjective dry eye symptoms

  Subjective symptoms of dry eye, reported by patients, and gathered using a standardized questionnaire.

  Up to 6 months after surgery

Secondary Outcomes (3)

• Surgical success rate

  6 month after surgery

• Complications

  Up to 6 months after surgery

• Visual acuity

  Up to 6 months after surgery

Study Arms (2)

Cyclosporine

EXPERIMENTAL

In the first postoperative day following a standard, fornix-based trabeculectomy, ophthalmic emulsion of Cyclosporine A, 2%, every 4 hours for the first postoperative week and every 6 hours for the next 3 weeks will be prescribed for the patients.

Drug: Cyclosporine

Betamethasone

ACTIVE COMPARATOR

In the first postoperative day following a standard, fornix-based trabeculectomy, betamethasone eye drop, every 4 hours for the first postoperative week and every 6 hours for the next 3 weeks will be prescribed for the patients.

Drug: Betamethasone

Interventions

Cyclosporine DRUG

In study arm, ophthalmic emulsion of cyclosporine A 2% will be prescribed in postoperative phase.

Also known as: Cyclosporine A (Sina Darou)

Cyclosporine

Betamethasone DRUG

In control arm, betamethasone eye drop will be prescribed in postoperative period.

Also known as: Betasonate (Sina Darou)

Betamethasone

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• POAG patient with insufficient IOP control on maximal tolerable medical therapy (MTMT), undergoing primary trabeculectomy with MMC augmentation.

You may not qualify if:

• Age \<20 years
• History of previous ocular surgery in the same eye;
• Candidate for combined surgery;
• Pregnancy;
• Breast feeding;
• Monocular subject;
• Allergy to any topical antiglaucoma medication or cyclosporine

Sponsors & Collaborators

• Mashhad University of Medical Sciences: lead

Study Sites (1)

Khatam Eye Hospital

Mashhad, Khorasan Razavi, 91959-61151, Iran

Location

MeSH Terms

Conditions

Glaucoma, Open-Angle; Glaucoma

Interventions

Cyclosporine; Betamethasone

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Intervention Hierarchy (Ancestors)

Cyclosporins; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Steroids, Fluorinated

Study Officials

• Ramin Daneshvar, MD, MSc

  Eye Research Center, Cornea Research Center, Mashhad University of Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Ramin Daneshvar

Study Record Dates

• First Submitted: April 6, 2014
• First Posted: April 15, 2014
• Study Start: April 1, 2014
• Primary Completion: November 1, 2014
• Study Completion: February 1, 2015
• Last Updated: April 21, 2015

Record last verified: 2015-04

Locations

IR (1)