Phase 4
N=20
Intracanalicular Dexamethasone Insert for Post-Corneal Cross-Linking Inflammation and Pain- The LINK Study
Keratoconus, Unstable · Collagen Crosslinking · Postoperative Pain
Bottom Line
View on ClinicalTrials.gov: NCT04168112 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Jan 2024
Primary outcome: Primary: Change in Degree of Postoperative Pain Between Groups From Date of Surgery Through 1 Month Post-CXL (Day of Surgery, Postoperative Days 1 ,3, 7, Postoperative Weeks 2 ,3 and 4) — 6.4; 6.6; 1.3; 2 score on a scale from 0 - 10
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Dextenza (Drug); Prednisolone Acetate (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Sight Medical Doctors PLLC
- Primary completion
- Oct 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Degree of Postoperative Pain Between Groups From Date of Surgery Through 1 Month Post-CXL (Day of Surgery, Postoperative Days 1 ,3, 7, Postoperative Weeks 2 ,3 and 4) |
6.4; 6.6; 1.3; 2; 0.2; 0 | — |
| PRIMARY Degree and Improvement of Ocular Surface Inflammation Between Groups From Date of Surgery Through 1 Month Post-CXL (Day of Surgery, Postoperative Days 1 ,3, 7, Postoperative Weeks 2 ,3 and 4) |
0.5; 0.5; 0.5; 0.5; 0; 0 | — |
| SECONDARY Rate of Corneal Re-epithelialization |
100; 100; 37.75; 34.75; 7.85; 6 | — |
| SECONDARY Subjective 'Ease of Postoperative Care' for Patients Receiving Standard Topical Steroid Eye Drop Taper vs. Dexamethasone Insert |
8; 10; 0; 0; 0; 0 | — |
| SECONDARY Notation of Need for Use of "Rescue" Pain Medication |
6; 6; 1; 1; 0; 0 | — |
Summary
There is no standard of care medication regimen for the management of pain and inflammation post-corneal crosslinking (CXL), although most cornea specialists agree on use of an antibiotic and steroid eye drop in the immediate postoperative period. However, steroid tapering schedule and use of additional topical non-steroidal anti-inflammatory (NSAID) eyedrops vary amongst practitioners. The goal of this study is to compare postoperative pain scores between patients receiving a tapering dose of topical steroids over 1-month post-CXL, versus those receiving an intracanalicular dexamethasone insert.
Eligibility Criteria
Inclusion Criteria
- Progressive keratoconus with planned corneal cross-linking in one or both eyes
- Age 18 years and older
- Ability to provide informed consent for procedures
- Ability to attend scheduled follow up visits
Exclusion Criteria
- Age less than 18
- Pregnancy/currently breast-feeding
- Inability to provide informed consent
- Documented adverse reaction to steroid (e.g. "steroid responder", allergy, etc)
- Punctal stenosis
- Previous corneal transplant surgery
- Systemic concomitant use of controlled substance for pain management (i.e. oxycodone)
- Concurrent use of topical steroid eye drops
- Systemic, topical or intravitreal steroid use within 1 month of baseline
- Active history of chronic or recurrent inflammatory eye disease in either eye
- History of ocular herpetic infection (inclusive of Herpes Simplex 1/2, Varicella Zoster, Epstein Barr, Cytomegalovirus)
- History of neurotrophic keratitis, uncontrolled diabetes, or other disease entities that may preclude proper healing
Data sourced from ClinicalTrials.gov (NCT04168112). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.