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Pain Relief After Corneal Collagen Cross-Linking

NCT06212830 · Status: NOT_YET_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2024-01-19

No results posted yet for this study

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.

Conditions

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

Interventions

DRUG

Gabapentin

Gabapentin 200 mg twice a day, starting from the night prior to the procedure and continue 48 hours after

DRUG

Targin

Targin 5 mg twice a day after the procedure for 48 hours

DRUG

NSAID

Nurofen (NSAID) 200 mg twice a day after the procedure for 48 hours

DRUG

Paracetamol

Paracetamol 500 mg every 4 hours during waking hours after the procedure for 48 hours

Sponsors & Collaborators

  • Assaf-Harofeh Medical Center

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
15 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-02-29
Primary Completion
2025-02-28
Completion
2025-08-31

Countries

  • Israel

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06212830 on ClinicalTrials.gov