Dextenza Versus Topical Steroid Eye Drops for Postoperative Management Following Corneal Crosslinking

MI-összefoglaló

A vizsgálat saját részvételi feltételeiből. Gép olvasta ki az oldalon álló regiszterszövegből, ezért tévedhet. Hogy ki vehet részt, azt a lenti regiszterszöveg és a vizsgálat csapata dönti el.

The trial is looking for people with keratoconus that is getting worse who are scheduled for corneal cross-linking with Photrexa in both eyes. One eye gets the Dextenza insert and the other gets PredForte steroid eye drops after the procedure.

Életkor

13 to 64 years

Nem

All

A betegség stádiuma

Progressive keratoconus, seen as increasing astigmatism or corneal curvature on corneal scans, or increasing cylinder error on refraction. Cornea at the centre must be >= 400 microns thick before surgery. Patients must need general anesthetic for the procedure.

Korábbi kezelés

People treated with immunosuppressants or oral steroids cannot join. People treated with immune-modifying drugs in the study eye cannot join.

A részvétel fő kizáró okai

• Past acute hydrops (sudden corneal swelling), severe corneal scarring, glaucoma, or eye inflammation or infection in the treated eye
• Past or current glaucoma or high eye pressure treatment, or eye pressure spikes, in either eye
• Blocked or narrowed tear duct, or tear duct smaller than 0.4 mm or 1.0 mm or larger
• Allergy to dexamethasone
• Active infection in the body, or severe illness the investigator thinks makes the study unsafe

A regiszter feltételei, szó szerint

Nézd meg, megfelelhetsz-e

Magadról válaszolj. Ez nem döntés: hogy részt vehetsz-e, azt csak a vizsgálat csapata mondhatja meg.

• 13 és 64 év között vagy?IgenNem

Mit akar kideríteni a vizsgálat

This study aims to compare the use of Dextenza, an FDA-approved intracanilular drug-eluting insert that is designed to deliver a tapered dose of dexamethasone to the ocular surface for 30 days, to the standard of care, or the use of a month-long topical prednisolone acetate 1% (PredForte) eye drops starting from four times daily. Following treatment, Dextenza resorbs and exits the nasolacrimal system without the need for removal. Three prior phase 3 clinical trials have demonstrated that Dextenza is equally efficacious to a month-long topical Pred Forte taper in the treatment of postoperative inflammation following cataract surgery. This proposed study strives to demonstrate the non-inferiority of using Dextenza to treat postoperative inflammation following corneal collagen crosslinking compared to standard of care eye drops in a randomized trial. By demonstrating Dextenza's non-inferiority to treatment postoperative inflammation, the investigators hope to provide an alternative modality of treatment to patients who are unable to cooperate with or tolerate postoperative topical eye drop regimens, allowing for improved adherence to necessary therapy and thus improved postoperative outcomes.

A vizsgálat 2 csoportja

• Dextenza insertA vizsgált kezelés

  This is a prospective, open-label, single-center, randomized, investigator-sponsored clinical study to compare dexamethasone intracanalicular insert and corticosteroid drops for post-treatment in patients undergoing epithelium-off corneal collagen cross linking surgery. The participant's worse eye will be randomized to one of the two treatments, and the fellow eye will receive the alternate treatment when undergoing the procedure at a subsequent date at least three weeks later. There will be a baseline/screening visit, a surgical/ insertion visit for each eye, and follow up visits over 6 months, for a total of 10 visits per patient. The study drug, DEXTNZA, is administered during the surgical procedure and the patient does not need to do any additional steps.

  Kezelés: Dextenza 0.4Mg Ophthalmic Insert

• topical prednisolone acetate 1% (PredForte) eye dropsMár használt kezelés, összehasonlításként

  This is a prospective, open-label, single-center, randomized, investigator-sponsored clinical study to compare dexamethasone intracanalicular insert and corticosteroid drops for post-treatment in patients undergoing epithelium-off corneal collagen cross linking surgery. The participant's worse eye will be randomized to one of the two treatments, and the fellow eye will receive the alternate treatment when undergoing the procedure at a subsequent date at least three weeks later. There will be a baseline/screening visit, a surgical/ insertion visit for each eye, and follow up visits over 6 months, for a total of 10 visits per patient. The patient will administer the anti-inflammatory steroid drops on the same 4 week post-operative schedule that is commonly used in standard of care. They will do one drop of Pred Forte in the affected eye 4 times a day for a week, 3 times a day for the second week, 2 times a day for the third week, and once a day for the fourth week.