Effect of Intraoperative Dexamethasone on Post-op Dry Eye

SR Cornea Consultants

Status and phase: Completed; Phase 4

Conditions: Dry Eye Syndromes

Treatments: Drug: Prednisolone Acetate 1% Oph Susp; Drug: dexamethasone intraocular suspension, 9%

Study type: Interventional

Funder types: Other

Identifiers

NCT04184999

SRCC10

Details and patient eligibility

About

To compare the signs and symptoms of dry eye after cataract surgery between subjects randomized to receive intraoperative dexamethasone in addition to the use of a standard topical post-op treatment regimen.

Full description

Forty patients requiring cataract surgery will be randomized to treatment of post-operative inflammation with a single intraoperative dexamethasone injection plus a standard course of topical ophthalmic corticosteroid drops or the standard treatment alone. Dry eye testing will be administered at baseline, 1 week and 3 weeks following surgery.

Enrollment: 40 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• undergoing bilateral cataract surgery

Exclusion criteria

• central corneal staining with fluorescein and/or a tear film osmolarity of greater than 340 in either eye

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Intracameral dexamethasone 9% + postoperative topical prednisolone acetate

Experimental group

Description:

dexamethasone intraocular suspension, 9% injected intracamerally at the time of cataract surgery + topical ophthalmic prednisolone acetate for 3 weeks post-operatively

Treatment:

Drug: dexamethasone intraocular suspension, 9%

Drug: Prednisolone Acetate 1% Oph Susp

postoperative topical prednisolone acetate

Active Comparator group

Description:

topical ophthalmic prednisolone acetate for 3 weeks post-operatively

Treatment:

Drug: Prednisolone Acetate 1% Oph Susp