A study to evaluate the effect of cyclosporine 2% eye drop on surgical result of glaucoma surgery (trabeculectomy)

Comparison of effect of Cyclosporine ophthalmic emulsion 2% and Betamethasone eye drop on intraocular pressure, conjunctival hyperemia and subjective dry eye symptoms following trabeculectomy in primary open angle glaucoma (POAG) patinets.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT138706111154N1

Enrollment

Registered

2013-09-23

Start date

2013-09-11

Completion date

Unknown

Last updated

2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

glaucoma. Primary Open-Angle Glaucoma

Interventions

Intervention 1: Case Group: 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

Treatment - Drugs

Case Group: 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 hour

Control Group: 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

Eligibility

Sex/Gender

All

Age

20 Years to No maximum

Inclusion criteria

Inclusion criteria: Inclusion Criteria: POAG patient with insufficient IOP control on maximal tolerable medical therapy (MTMT), undergoing primary trabeculectomy with MMC augmentation. Exclusion Criteria: 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

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Intraocular pressure (IOP). Timepoint: monthly. Method of measurement: Goldmann applanation tonometer (GAT).;Bleb morphology. Timepoint: monthly. Method of measurement: clinical observation and slit photography (IBAGS).;Subjective dry eye symptoms. Timepoint: monthly. Method of measurement: questionnaire.	—

Secondary

Measure	Time frame
Success rate. Timepoint: Mid-term success rate (6 month following surgery) would be evaluated. Method of measurement: clinical exam.;Complication rate. Timepoint: Midterm complication rate (6 month following surgery) would be evaluated. Method of measurement: clinical exam.;Visual acuity. Timepoint: monthly. Method of measurement: clinical exam (logMAR).	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactParisa Rajaei; Marzieh Saadat

Eye Research Center, Mashhad University of Medical Sciences

erc@mums.ac.ir+98 51 1728 9911

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026