Recruiting

Observational Study

Sponsor:

Vance Thompson Vision - MT

Code:

NCT04549935

Conditions

Patient Preference

Patient Outcomes

Post-Operative Inflammation

Grade of Post-Operative Cystoid Macular Edema

Rate of Post-Operative Cystoid Macular Edema

Eligibility Criteria

Sex: All

Age: 22 - 70+

Healthy Volunteers: Accepted

Interventions

Dextenza

Topical Prednisolone

Study Details

Brief summary:

To investigate the outcomes of patients undergoing bilateral RLE surgery with treatment of dexamethasone intracanilicular insert compared to topical standard care steroid. Desiged to look at patient preference comparing the insert to drops and will also look at patient outcomes including inflammatin and risk of cystoid macular edema post-operatively.

Conditions

Patient Preference

Patient Outcomes

Post-Operative Inflammation

Grade of Post-Operative Cystoid Macular Edema

Rate of Post-Operative Cystoid Macular Edema

Study ID

NCT04549935

Start date

Sep 14, 2020

Status verified date

Aug, 2020

Completion date

Aug 27, 2021

Anticipated

Primary completion date

Aug 27, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 22 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Any adult patient who is planned to undergo bilateral RLE surgery with BCVA 20/30 or better
  • 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 22 or above the age of 75
  • Patients who are pregnant (must be ruled out in a women of child-bearing age with pregnancy test).
  • Patients with active infectious ocular or extraocular disease.
  • Patients actively treated with local or systemic immunosuppression including systemic corticosteriods
  • Paitents with know hypersensitivity to Dexamethasone
  • Patients with severe disease that warrants critical attentino, deemed unsafe for the study by the investigator
  • Patients with a history of ocular inflammation or macular edema
  • Patients with allergy or inability to receive intracameral antibiotic
  • Patients on systemic non-steroidal anti-inflammatory drugs (NSAID) grater than 1,200 mg/day
  • Patient with a corticosteriod implant (i.e. Ozurdex).
  • Patient with corneal pathology which pre-disposes them to unsatisfactory outcomes

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Group A Dextenza

Drug: Dextenza 0.4mg Opthalmic Insert The insert, containing 0.4 mg of active pharmaceutical product, is placed within the canaliculus to provide a sustained and tapered delivery of drug to the ocular surface over 30 days after a one-time insertion, The attributes of the insert reduce risks for improper corticosteriod tapering and unwanted peaks and troughs in drug concentration.

active comparator: Group B Topical Prednisolone

Drug: Topical Prednisolone Standard of care topical drop treatment

Interventions

Dextenza

Dextenza 0.4mg

Topical Prednisolone

Standard of care topical drop treatment

Primary outcome measure

  • Patient Preference [ Time Frame: Through Month 1 ]

Central Contacts and Locations

Locations

Briana Parker

Recruiting

Bozeman, Montana, United States, 59718

Contacts

Briana Parker

406-599-5961briana.parker@vancethompsonvision.com

Keeley Puls

605 371-7075kpuls@vancethompsonvision.com

Principal Investigator:

Russell Swan, MD

More Information

Sponsor

Vance Thompson Vision - MT

Last update posted

Sep 16, 2020

Last verified

Aug, 2020

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Vance Thompson Vision - MT on 2020-09-16.