Pain Relief After Corneal Collagen Cross-Linking

Early Phase 1

Not yet recruiting

• Conditions: Provide Evidence-based Recommendations for Clinicians to Optimize Pain Control After CXL
• Interventions: Drug: Gabapentin; Drug: Targin; Drug: NSAID; Drug: Paracetamol

• Registration Number: NCT06212830
• Lead Sponsor: Assaf-Harofeh Medical Center

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-01
• Study First Submitted: 2024-01-09
• Study First Submitted QC: 2024-01-09
• Last Update Submitted: 2024-01-09
• Study First Posted: 2024-01-19
• Last Update Posted: 2024-01-19
• Study Start: 2024-02
• Primary Completion: 2025-02
• Study Completion: 2025-08

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 51

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Gabapentin	NSAID	This group will receive a combination of drugs including: Gabapentin, NSAIDS and Paracetamol.
Targin	NSAID	This group will receive a combination of drugs including: Targin, NSAIDS and Paracetamol.
Control	NSAID	This group will receive a combination of drugs including: NSAIDS and Paracetamol.
Control	Paracetamol	This group will receive a combination of drugs including: NSAIDS and Paracetamol.
Gabapentin	Gabapentin	This group will receive a combination of drugs including: Gabapentin, NSAIDS and Paracetamol.
Gabapentin	Paracetamol	This group will receive a combination of drugs including: Gabapentin, NSAIDS and Paracetamol.
Targin	Targin	This group will receive a combination of drugs including: Targin, NSAIDS and Paracetamol.
Targin	Paracetamol	This group will receive a combination of drugs including: Targin, NSAIDS and Paracetamol.

Primary Outcome Measures

Name	Time	Method
Pain questionnaires	The questionnaire will be asked 2, 6, 24 48 and 72 hours after surgery.

Trial Locations

Locations (1)

Shamir Medical Center (Assaf Harofeh); 🇮🇱 Be'er Ya'aqov, Israel