Assessing Dextenza Insert After SMILE Procedure

  • STATUS
    Recruiting
  • participants needed
    20
  • sponsor
    William Wiley, MD
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Updated on 5 August 2020
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Summary

This three-month prospective, open-label, single-center, randomized investigator initiated clinical study seeks to investigate the efficacy of DEXTENZA when placed in the lower canaliculus (study eye) compared to topical corticosteroids (control eye) following bilateral SMILE surgery. In addition, the study will evaluate physician assessment of ease of DEXTENZA insertion

Description

4.1 Study Population The study aims to enroll 20 patients undergoing bilateral SMILE.

4.1.1 Inclusion Criteria

A patient's study eye must meet the following criteria to be eligible for inclusion in the

study
  • Age 18 years and older
  • Scheduled for bilateral SMILE surgery
  • Willing and able to comply with clinic visits and study related procedures
  • Willing and able to sign the informed consent form

4.1.2 Exclusion Criteria

A patient who meets any of the following criteria will be excluded from the study:

  • Patients under the age of 18.
  • Pregnancy (must be ruled out in women of child-bearing age with pregnancy test)
  • Active infectious systemic disease
  • Active infectious ocular or extraocular disease
  • Obstructed nasolacrimal duct in the study eye(s)
  • Hypersensitivity to dexamethasone
  • Patients being treated with immunomodulating agents in the study eye(s)
  • Patients being treated with immunosuppressants and/or oral steroids Patients with severe disease that warrants critical attention, deemed unsafe for the study by the investigator

Details
Condition Post Procedural Infection
Age 18years - 100years
Treatment Dexamethasone ophthalmic insert 0.4 mg
Clinical Study IdentifierNCT04380857
SponsorWilliam Wiley, MD
Last Modified on5 August 2020

Eligibility

 Yes No Not Sure

Inclusion Criteria

Age 18 years and older
Scheduled for bilateral SMILE surgery
Willing and able to comply with clinic visits and study related procedures
Willing and able to sign the informed consent form

Exclusion Criteria

Patients under the age of 18
Pregnancy (must be ruled out in women of child-bearing age with pregnancy test)
Active infectious systemic disease
Active infectious ocular or extraocular disease
Obstructed nasolacrimal duct in the study eye(s)
Hypersensitivity to dexamethasone
Patients being treated with immunomodulating agents in the study eye(s)
Patients being treated with immunosuppressants and/or oral steroids Patients with severe disease that warrants critical attention, deemed unsafe for the study by the investigator
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