Pain Relief After Corneal Collagen Cross-Linking
Enhancing Pain Relief After Corneal Collagen Cross-Linking: Exploring New Post-Surgical Treatments
1 other identifier
interventional
51
1 country
1
Brief Summary
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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for early_phase_1
Started Feb 2024
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 9, 2024
CompletedFirst Posted
Study publicly available on registry
January 19, 2024
CompletedStudy Start
First participant enrolled
February 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2025
CompletedJanuary 19, 2024
January 1, 2024
1 year
January 9, 2024
January 9, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Pain questionnaires
The questionnaire will be asked 2, 6, 24 48 and 72 hours after surgery.
Study Arms (3)
Gabapentin
ACTIVE COMPARATORThis group will receive a combination of drugs including: Gabapentin, NSAIDS and Paracetamol.
Targin
ACTIVE COMPARATORThis group will receive a combination of drugs including: Targin, NSAIDS and Paracetamol.
Control
ACTIVE COMPARATORThis group will receive a combination of drugs including: NSAIDS and Paracetamol.
Interventions
Gabapentin 200 mg twice a day, starting from the night prior to the procedure and continue 48 hours after
Paracetamol 500 mg every 4 hours during waking hours after the procedure for 48 hours
Eligibility Criteria
You may qualify if:
- Patients above the age of 15 years
- Patients who are undergoing CXL treatment
You may not qualify if:
- Renal and/or hepatic failure
- Patients under the age of 15
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Shamir Medical Center (Assaf Harofeh)
Be’er Ya‘aqov, 7033001, Israel
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
January 9, 2024
First Posted
January 19, 2024
Study Start
February 1, 2024
Primary Completion
February 1, 2025
Study Completion
August 1, 2025
Last Updated
January 19, 2024
Record last verified: 2024-01
Data Sharing
- IPD Sharing
- Will not share