The Effectiveness and Safety of FK-506 for the Treatment of Posner-Schlossman Syndrome

Peking University

Status: Unknown

Conditions: Posner Schlossman Syndrome

Treatments: Drug: Prednisolone Acetate 1% Oph Susp; Drug: FK-506 (Drug)

Study type: Interventional

Funder types: Other

Identifiers

NCT04590183

IRB00006761-M2020059

Details and patient eligibility

About

To evaluate the effectiveness and safety of tacrolimus eye drops (FK-506) in the treatment of Posner-Schlossman Syndrome. It is expected to collect 30 patients with PSS who are in the Ophthalmology Department of Peking University Third Hospital. The included PSS patients were divided into experimental group and control group using simple randomization method. Among them, the experimental group was treated with FK-506 twice a day, and the control group was treated with prednisolone acetate ophthalmic suspension 1% 4 times a day.

For all PSS patients whose intraocular pressure is higher than 30mmHg, also add brinzolamide eye drops 3 times a day. Best corrected visual acuity, Goldmann intraocular pressure, anterior section photographs, corneal endothelial cells，corneal confocal microscope, Heidelberg retinal nerve analysis, Octopus visual field were examined on baseline and 1 week, 2 weeks, 3 weeks, 4 weeks after the treatment.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinical diagnosis of PSS Must be able to communicate with doctor and understand this study

Exclusion criteria

• Fuchs syndrome

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

The experimental group

Experimental group

Treatment:

Drug: FK-506 (Drug)

The control group

Sham Comparator group

Treatment:

Drug: Prednisolone Acetate 1% Oph Susp