Provide Evidence-based Recommendations for Clinicians to Optimize Pain Control After CXLEarly Phase 1NCT06212830
Pain Relief After Corneal Collagen Cross-Linking
A Early Phase 1 study testing Gabapentin, Targin and NSAID in people with Provide Evidence-based Recommendations for Clinicians to Optimize Pain Control After CXL, run by Assaf-Harofeh Medical Center at 1 site in Israel.
Trial 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… Read more about this study
- Who is it for?
- Ages 15 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Provide Evidence-based Recommendations for Clinicians to Optimize Pain Control After CXL
- What is being tested?
- Gabapentin, Targin and NSAID
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteIsrael
- Study dates
- Feb 2024to Aug 2025
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 100 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients above the age of 15 years
- Patients who are undergoing CXL treatment
Who cannot join
- Renal and/or hepatic failure
- Patients under the age of 15
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Being tested
- Gabapentin, Targin, NSAID, Paracetamol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GabapentinDrug
Gabapentin 200 mg twice a day, starting from the night prior to the procedure and continue 48 hours after
TarginDrug
Targin 5 mg twice a day after the procedure for 48 hours
NSAIDDrug
Nurofen (NSAID) 200 mg twice a day after the procedure for 48 hours
ParacetamolDrug
Paracetamol 500 mg every 4 hours during waking hours after the procedure for 48 hours
| Study group | Role | What they receive |
|---|---|---|
| Gabapentin | Active comparator | This group will receive a combination of drugs including:
Gabapentin, NSAIDS and Paracetamol. Receives: Drug: Gabapentin; Drug: NSAID; Drug: Paracetamol |
| Targin | Active comparator | This group will receive a combination of drugs including:
Targin, NSAIDS and Paracetamol. Receives: Drug: Targin; Drug: NSAID; Drug: Paracetamol |
| Control | Active comparator | This group will receive a combination of drugs including:
NSAIDS and Paracetamol. Receives: Drug: NSAID; Drug: Paracetamol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain questionnaires
Measured: The questionnaire will be asked 2, 6, 24 48 and 72 hours after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2024
- Study startFeb 2024 (estimated)
- Primary completionFeb 2025 (estimated)
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Provide Evidence-based Recommendations for Clinicians to Optimize Pain Control After CXLStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 51 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assaf-Harofeh Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Adi Einan-Lifshitz, Assaf-Harofeh Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06212830
- Sponsor's protocol ID
- 177-23
- Status last verified
- Jan 2024
- First submitted
- 9 Jan 2024
- Last updated
- 19 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Pain Relief After Corneal Collagen Cross-Linking: Exploring New Post-Surgical Treatments
- ClinicalTrials.gov ID
- NCT06212830
- Acronym / sponsor ID
- 177-23
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 51 participants (estimated)
- Lead sponsor
- Assaf-Harofeh Medical CenterOther government
- Study start
- Feb 2024 (estimated)
- Primary completion
- Feb 2025 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 19 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Gabapentin | Active comparator | Drug: Gabapentin, Drug: NSAID, Drug: ParacetamolThis group will receive a combination of drugs including: Gabapentin, NSAIDS and Paracetamol. |
| Targin | Active comparator | Drug: Targin, Drug: NSAID, Drug: ParacetamolThis group will receive a combination of drugs including: Targin, NSAIDS and Paracetamol. |
| Control | Active comparator | Drug: NSAID, Drug: ParacetamolThis group will receive a combination of drugs including: NSAIDS and Paracetamol. |
Who may qualify
- Ages
- 15 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients above the age of 15 years
- Patients who are undergoing CXL treatment
Key exclusion criteria (2 listed)
- Renal and/or hepatic failure
- Patients under the age of 15
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GabapentinGabapentin 200 mg twice a day, starting from the night prior to the procedure and continue 48 hours after | Drug | Gabapentin |
| TarginTargin 5 mg twice a day after the procedure for 48 hours | Drug | Targin |
| NSAIDNurofen (NSAID) 200 mg twice a day after the procedure for 48 hours | Drug | Control, Gabapentin, Targin |
| ParacetamolParacetamol 500 mg every 4 hours during waking hours after the procedure for 48 hours | Drug | Control, Gabapentin, Targin |
Primary outcome
Pain questionnaires
Time frame: The questionnaire will be asked 2, 6, 24 48 and 72 hours after surgery.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2024.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Gabapentin, Targin and NSAID in people with Provide Evidence-based Recommendations for Clinicians to Optimize Pain Control After CXL, run by Assaf-Harofeh Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain questionnaires (time frame: The questionnaire will be asked 2, 6, 24 48 and 72 hours after surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2024.