Pain Relief After Corneal Collagen Cross-Linking

NCT ID: NCT06212830

Last Updated: 2024-01-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

EARLY_PHASE1

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-29

Study Completion Date

2025-08-31

Brief Summary

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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

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Gabapentin

This group will receive a combination of drugs including:

Gabapentin, NSAIDS and Paracetamol.

Group Type ACTIVE_COMPARATOR

Gabapentin

Intervention Type DRUG

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

NSAID

Intervention Type DRUG

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

Paracetamol

Intervention Type DRUG

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

Targin

This group will receive a combination of drugs including:

Targin, NSAIDS and Paracetamol.

Group Type ACTIVE_COMPARATOR

Targin

Intervention Type DRUG

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

NSAID

Intervention Type DRUG

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

Paracetamol

Intervention Type DRUG

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

Control

This group will receive a combination of drugs including:

NSAIDS and Paracetamol.

Group Type ACTIVE_COMPARATOR

NSAID

Intervention Type DRUG

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

Paracetamol

Intervention Type DRUG

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

Interventions

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Gabapentin

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

Intervention Type DRUG

Targin

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

Intervention Type DRUG

NSAID

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

Intervention Type DRUG

Paracetamol

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

15 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Assaf-Harofeh Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Adi Einan-Lifshitz

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Shamir Medical Center (Assaf Harofeh)

Be’er Ya‘aqov, , Israel

Site Status

Countries

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Israel

Other Identifiers

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177-23

Identifier Type: -

Identifier Source: org_study_id

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