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NCT04168112 · ClinicalTrials.gov registry record · Phase 4
Intracanalicular Dexamethasone Insert for Post-Corneal Cross-Linking Inflammation and Pain- The LINK Study
A Phase 4 study of Postoperative Pain and Keratoconus, Unstable, sponsored by Sight Medical Doctors P.
- Completed
- Registry status
- Phase 4
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT04168112: Completed Phase 4 study of Postoperative Pain and Keratoconus, Unstable, sponsored by Sight Medical Doctors P.
NCT04168112 is a Phase 4 study of Postoperative Pain and Keratoconus, Unstable that has completed, run by Sight Medical Doctors P. The registered enrollment target is 20 participants, below the 232-participant average among 120 other Postoperative Pain trials with a reported enrollment target (91% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04168112, a Phase 4 study of Postoperative Pain and Keratoconus, Unstable, has completed, sponsored by Sight Medical Doctors P.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Utilizing the standardized Wong-Baker visual analog pain scale, graded from 0 to 10 (no pain to increasingly worse pain (worst at 10/10))
Conditions Studied
Interventions
- DRUG Dextenza
- DRUG Prednisolone Acetate
Study Locations (1)
New York
- SightMD - Babylon
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2020-02-12 |
| Est. Completion | 2023-04-05 |
| Phase | Phase 4 |
What the finished NCT04168112 record still lists
NCT04168112 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 232-participant average among 120 other Postoperative Pain trials with a reported enrollment target (91% lower).
The record links to 3 conditions, with Postoperative Pain appearing as the primary indexed condition, and to 2 interventions - of which Dextenza is the first listed.
NCT04168112 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT04168112 about?
NCT04168112 is a clinical study titled "Intracanalicular Dexamethasone Insert for Post-Corneal Cross-Linking Inflammation and Pain- The LINK Study". 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 additi...
What is the current status of trial NCT04168112?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 20 participants. The study started on 2020-02-12. Estimated completion is 2023-04-05.
What conditions does trial NCT04168112 study?
This clinical trial studies the following conditions: Postoperative Pain, Keratoconus, Unstable, Collagen Crosslinking.
What interventions are being tested in trial NCT04168112?
The interventions under investigation include: Dextenza (DRUG), Prednisolone Acetate (DRUG).
Who is sponsoring clinical trial NCT04168112?
This trial is sponsored by Sight Medical Doctors P, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04168112 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Postoperative Pain
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04168112's enrollment target sits among peer trials
20 118th of 120 higher than 3 of 120 other Postoperative Pain trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Postoperative Pain trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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