18 and older, any sex, with Keratoconus, Unstable or Collagen Crosslinking. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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)Primary· Assessed at 1 day of surgery, postoperative days 1 ,3, 7, postoperative weeks 2 ,3 and 4 (7 visits total)
Utilizing the standardized Wong-Baker visual analog pain scale, graded from 0 to 10 (no pain to increasingly worse pain (worst at 10/10))
Postoperative day 0
Group
Value
95% CI
Group A
6.4
± 1.3
Group B
6.6
± 1.62
Postoperative day 1
Group
Value
95% CI
Group A
1.3
± 0.45
Group B
2
± 1.18
Postoperative day 3
Group
Value
95% CI
Group A
0.2
± 0.4
Group B
0
± 0
Postoperative day 7
Group
Value
95% CI
Group A
0
± 0
Group B
0
± 0
Postoperative week 2
Group
Value
95% CI
Group A
0
± 0
Group B
0
± 0
Postoperative week 3
Group
Value
95% CI
Group A
0
± 0
Group B
0
± 0
Postoperative week 4
Group
Value
95% CI
Group A
0
± 0
Group B
0
± 0
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)Primary· assessed at day of surgery, postoperative days 1 ,3, 7, postoperative weeks 2 ,3 and 4 (7 visits total)
Assessment of corneal edema/cells (if any), degree of conjunctiva injection (if any) Grading will be from 0 to 4, with "0" being no conjunctival injection, and "4" indicating severe, diffuse conjunctival injection. Presence of corneal cells will be noted if present or absent.
date of surgery
Group
Value
95% CI
Group A
0.5
± 0
Group B
0.5
± 0
postoperative day 1
Group
Value
95% CI
Group A
0.5
± 0
Group B
0.5
± 0
postoperative day 3
Group
Value
95% CI
Group A
0
± 0
Group B
0
± 0
postoperative day 7
Group
Value
95% CI
Group A
0
± 0
Group B
0
± 0
postoperative week 2
Group
Value
95% CI
Group A
0
± 0
Group B
0
± 0
postoperative week 3
Group
Value
95% CI
Group A
0
± 0
Group B
0
± 0
postoperative week 4
Group
Value
95% CI
Group A
0
± 0
Group B
0
± 0
Rate of Corneal Re-epithelializationSecondary· Assessed at 1 day of surgery, postoperative days 1 ,3, 7, postoperative weeks 2 ,3 and 4 (7 visits total)
Evaluation of rate of corneal re-epithelialization post-crosslinking at 1 day of surgery, postoperative days 1 ,3, 7, postoperative weeks 2 ,3 and 4
Day of surgery
Group
Value
95% CI
Group A
100
± 0
Group B
100
± 0
Postoperative day 1
Group
Value
95% CI
Group A
37.75
± 5.35
Group B
34.75
± 7.15
Postoperative day 3
Group
Value
95% CI
Group A
7.85
± 2.47
Group B
6
± 2
Postoperative day 7
Group
Value
95% CI
Group A
0
± 0
Group B
0
± 0
postoperative week 2
Group
Value
95% CI
Group A
0
± 0
Group B
0
± 0
Postoperative week 3
Group
Value
95% CI
Group A
0
± 0
Group B
0
± 0
Postoperative week 4
Group
Value
95% CI
Group A
0
± 0
Group B
0
± 0
Subjective 'Ease of Postoperative Care' for Patients Receiving Standard Topical Steroid Eye Drop Taper vs. Dexamethasone InsertSecondary· postoperative week 4 (POW4)
Questionnaire at final visit regarding ease of postoperative eye drop use
Q1. "Were directions regarding eyedrop use post-CXL easy to follow?
Group
Value
95% CI
Group A
8
Group B
10
Group A
0
Group B
0
Q2. "Was it cumbersome to use eyedrops for more than 10 days?"
Group
Value
95% CI
Group A
0
Group B
0
Group A
8
Group B
10
Q3. "Was it difficult to remember to use postoperative eye drops?"
Group
Value
95% CI
Group A
0
Group B
0
Group A
8
Group B
10
Notation of Need for Use of "Rescue" Pain MedicationSecondary· Assessement of use of additional/adjunctive pain/antiinflammatory medications will be done for each patient at postoperative days 1 ,3, 7, postoperative weeks 2 ,3 and 4 (7 visits total)
Use of oral non-steroidal anti-inflammatory (NSAID), acetaminophen, prescribed pain medication) between groups
POD 0 use of pain medication
Group
Value
95% CI
Group A
6
Group B
6
POD 1 use of pain medication
Group
Value
95% CI
Group A
1
Group B
1
POD 3 use of pain medication
Group
Value
95% CI
Group A
0
Group B
0
POD 7 use of pain medication
Group
Value
95% CI
Group A
0
Group B
0
POW2 use of pain medication
Group
Value
95% CI
Group A
0
Group B
0
POW3 use of pain medication
Group
Value
95% CI
Group A
0
Group B
0
POW4 use of pain medication
Group
Value
95% CI
Group A
0
Group B
0
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Sight Medical Doctors PLLC
Last refreshed: 30 January 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04168112.