Clinical trial

Enhancing Pain Relief After Corneal Collagen Cross-Linking: Exploring New Post-Surgical Treatments

Name
177-23
Description
Keratoconus is a progressive corneal ectasia that can lead to significant visual impairment and decreased quality of life. The introduction of corneal cross-linking (CXL) with riboflavin and ultraviolet-A (UVA) light has revolutionized the treatment of keratoconus by increasing corneal rigidity and arresting disease progression. The epithelium-off protocol, which induces heightened post-surgical discomfort, is the prevailing approach. Despite the success of CXL, postoperative pain is a common side effect that can negatively impact patients' quality of life and impede recovery. Pain management after CXL is essential for optimizing patient outcomes and satisfaction. Systemic painkillers, though not researched enough, may potentially aid in healing and recovery, minimizing complications and discomfort for the patient. In this study we will provide evidence-based recommendations for clinicians to optimize pain control after CXL in collaboration with pain specialists.
Trial arms
Trial start
2024-02-01
Estimated PCD
2025-02-01
Trial end
2025-08-01
Status
Not yet recruiting
Phase
Early phase I
Treatment
Gabapentin
Gabapentin 200 mg twice a day, starting from the night prior to the procedure and continue 48 hours after
Arms:
Gabapentin
Targin
Targin 5 mg twice a day after the procedure for 48 hours
Arms:
Targin
NSAID
Nurofen (NSAID) 200 mg twice a day after the procedure for 48 hours
Arms:
Control, Gabapentin, Targin
Paracetamol
Paracetamol 500 mg every 4 hours during waking hours after the procedure for 48 hours
Arms:
Control, Gabapentin, Targin
Size
51
Primary endpoint
Pain questionnaires
The questionnaire will be asked 2, 6, 24 48 and 72 hours after surgery.
Eligibility criteria
Inclusion Criteria: * Patients above the age of 15 years * Patients who are undergoing CXL treatment Exclusion Criteria: * Renal and/or hepatic failure * Patients under the age of 15
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['EARLY_PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'SUPPORTIVE_CARE', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}}, 'enrollmentInfo': {'count': 51, 'type': 'ESTIMATED'}}
Updated at
2024-01-19

1 organization

4 products

1 indication

Product
Gabapentin
Product
Targin
Product
NSAID