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Effect of Intraoperative Dexamethasone on Post-op Dry Eye

NCT ID: NCT04184999

Last Updated: 2023-11-22

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-10

Study Completion Date

2019-12-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Dry Eye Syndromes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized, controlled prospective study.
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Intracameral dexamethasone 9% + postoperative topical prednisolone acetate

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

Group Type EXPERIMENTAL

dexamethasone intraocular suspension, 9%

Intervention Type DRUG

single dose intracameral corticosteroid

Prednisolone Acetate 1% Oph Susp

Intervention Type DRUG

topical ophthalmic steroid drop

postoperative topical prednisolone acetate

topical ophthalmic prednisolone acetate for 3 weeks post-operatively

Group Type ACTIVE_COMPARATOR

Prednisolone Acetate 1% Oph Susp

Intervention Type DRUG

topical ophthalmic steroid drop

Interventions

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dexamethasone intraocular suspension, 9%

single dose intracameral corticosteroid

Intervention Type DRUG

Prednisolone Acetate 1% Oph Susp

topical ophthalmic steroid drop

Intervention Type DRUG

Other Intervention Names

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Dexycu

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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SR Cornea Consultants

OTHER

Sponsor Role lead

Responsible Party

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Sanjay N Rao, MD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sanjay Rao, MD

Role: PRINCIPAL_INVESTIGATOR

SR Cornea Conslutants

Locations

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Hauser Ross Surgical Center

Sycamore, Illinois, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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SRCC10

Identifier Type: -

Identifier Source: org_study_id