Pain Relief After Corneal Collagen Cross-Linking

January 9, 2024 updated by: Adi Einan-Lifshitz, Assaf-Harofeh Medical Center

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

51

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Be'er Ya'aqov, Israel, 7033001
        • Shamir Medical Center (Assaf Harofeh)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Gabapentin

This group will receive a combination of drugs including:

Gabapentin, NSAIDS and Paracetamol.
Drug: Gabapentin
Gabapentin 200 mg twice a day, starting from the night prior to the procedure and continue 48 hours after
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
Active Comparator: Targin

This group will receive a combination of drugs including:

Targin, NSAIDS and Paracetamol.
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
Drug: Targin
Targin 5 mg twice a day after the procedure for 48 hours
Active Comparator: Control

This group will receive a combination of drugs including:

NSAIDS and Paracetamol.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pain questionnaires
Time Frame: The questionnaire will be asked 2, 6, 24 48 and 72 hours after surgery.
The questionnaire will be asked 2, 6, 24 48 and 72 hours after surgery.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assaf-Harofeh Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2024

Primary Completion (Estimated)

February 1, 2025

Study Completion (Estimated)

August 1, 2025

Study Registration Dates

First Submitted

January 9, 2024

First Submitted That Met QC Criteria

January 9, 2024

First Posted (Estimated)

January 19, 2024

Study Record Updates

Last Update Posted (Estimated)

January 19, 2024

Last Update Submitted That Met QC Criteria

January 9, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 177-23

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Gabapentin

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mauritania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe