Pain Relief After Corneal Collagen Cross-Linking

Shamir Medical Center (Assaf-Harofeh)

Status and phase: Not yet enrolling; Early Phase 1

Conditions: Provide Evidence-based Recommendations for Clinicians to Optimize Pain Control After CXL

Treatments: Drug: Targin; Drug: Paracetamol; Drug: NSAID; Drug: Gabapentin

Study type: Interventional

Funder types: Other

Identifiers

NCT06212830

177-23

Details and patient eligibility

About

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.

Enrollment: 51 estimated patients

Sex: All

Ages: 15 to 100 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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51 participants in 3 patient groups

Gabapentin

Active Comparator group

Description:

This group will receive a combination of drugs including: Gabapentin, NSAIDS and Paracetamol.

Treatment:

Drug: NSAID

Drug: Paracetamol

Drug: Gabapentin

Targin

Active Comparator group

Description:

This group will receive a combination of drugs including: Targin, NSAIDS and Paracetamol.

Treatment:

Drug: NSAID

Drug: Targin

Drug: Paracetamol

Control

Active Comparator group

Description:

This group will receive a combination of drugs including: NSAIDS and Paracetamol.

Treatment:

Drug: NSAID

Drug: Paracetamol