Analgesic eye drops for pain control after a refractive procedure
| ISRCTN | ISRCTN21394752 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN21394752 |
| Secondary identifying numbers | 4NPR19 |
- Submission date
- 05/03/2021
- Registration date
- 08/03/2021
- Last edited
- 13/01/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Plain English summary of protocol
Background and study aims
Photorefractive keratectomy is a well-established safe method of surgery that uses a laser to treat vision problems caused by refractive errors. Pain in the first few days after the procedure can be annoying to the patients, and there are many drugs that could be used topically (eye drops) to control this pain. However, they have other unwanted effects like prolonging the time of healing after the procedure. The aim of this study is to find out if topical nalbuphine hydrochloride is effective in controlling postoperative pain, and which concentration is more effective at preventing pain and whether this pain control is associated with any unwanted side effects. Nalbuphine hydrochloride is a well known potent analgesic used after many major surgeries, it will be reconstituted into eye drops form to be used topically in the first 3 days after the surgery.
Who can participate?
Patients aged over 20 who are going to have refractive surgery to correct a low or moderate error of refraction
What does the study involve?
The study involves patients using eye drops from a pre-prepared (analgesic eye drops) bottle without knowing its true content in the first 3 days following the refractive procedure. Some patients will receive a bottle with a certain concentration of the analgesic, others will receive a higher concentration of the analgesic and the remaining patients will receive only artificial tears. The patients are asked to record their pain and the number of times they use the eye drops in the first 3 days and they attend a daily examination in the first 8 days following the procedure. The last follow-up visit is at the end of the third postoperative month to measure the final visual acuity and refractive outcome.
What are the possible benefits and risks of participating?
The participants are expected to have better pain control in the first days after the refractive procedures. Possible risks include delayed healing which can be assessed by daily examination of the patients.
Where is the study run from?
Delta Medical Center (Egypt)
When is the study starting and how long is it expected to run for?
April 2019 to November 2020
Who is funding the study?
Delta Medical Center (Egypt)
Who is the main contact?
Dr Hala Mattout
HKMtoot@medicine.zu.edu.eg
Contact information
Scientific
16 Ali ben Abitaleb Street
Velal Elgamaa
Zagazig
44111
Egypt
 ORCID ID |
0000-0003-4809-6745 |
|---|---|
| Phone | +20 (0)01227112632 |
| HKMtoot@medicine.zu.edu.eg |
Study information
| Study design | Single-center interventional double-blinded randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | ISRCTN21394752_PIS_Arabic.docx |
| Scientific title | The use of topical nalbuphine in different concentrations to control pain after photorefractive keratectomy |
| Study objectives | Topical nalbuphine hydrochloride eye drops relieve pain after photorefractive keratectomy and this effect is higher with a 2 mg/ml concentration than with a 1 mg/ml concentration. |
| Ethics approval(s) | Approved 16/6/2019, Delta Medical Center Research Ethics Committee (Alexandria Street from Gesr Elnile Street, Mitghamr, Egypt; +20 (0)504906761; healthresethics@deltahealth.online), ref: 4NPR19 |
| Health condition(s) or problem(s) studied | Pain following photorefractive keratectomy procedure |
| Intervention | The patients are randomized using computer-generated randomization tables to three groups: topical nalbuphine postoperative with a concentration of 2 mg/ml (group A), topical nalbuphine with a concentration of 1 mg/ml (group B) and a control group receiving artificial tears only (group C). The patients are asked to record their pain and the number of times they use the eye drops in the first 3 days and they attend a daily examination in the first 8 days following the procedure. The last follow-up visit is at the end of the third postoperative month to measure the final visual acuity and refractive outcome. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Nalbuphine hydrochloride |
| Primary outcome measure | Pain measured using a numeric rating scale (recording the maximum pain level) in the first 3 postoperative days |
| Secondary outcome measures | 1. Number of analgesic eye drops applications recorded by patients in the first 3 postoperative days 2. Time needed for complete epithelial healing assessed by slit-lamp examination daily in the first 8 postoperative days 3. Best corrected visual acuity (converted to LogMAR) measured by Landolt chart at the end of the third postoperative month 4. Refraction measured by autorefractometer at the end of the third postoperative month |
| Overall study start date | 01/04/2019 |
| Completion date | 15/11/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 200 |
| Total final enrolment | 189 |
| Key inclusion criteria | 1. Age above 20 years 2. Error of refraction is less than 4 D spherical equivalent 3. Minimum corneal thickness is more than 480 microns 4. Absence of collagen diseases 5. Absence of corneal surface abnormalities 6. Absence of ocular diseases other than the refractive error 7. No history of concurrent use of systemic or topical analgesics |
| Key exclusion criteria | 1. Age below 20 years 2. Error of refraction is more than 4 D spherical equivalent 3. Minimum corneal thickness is less than 480 microns 4. Presence of collagen diseases 5. Presence of corneal surface abnormalities 6. Presence of ocular diseases other than the refractive error 7. History of concurrent use of systemic or topical analgesics |
| Date of first enrolment | 01/07/2019 |
| Date of final enrolment | 30/07/2020 |
Locations
Countries of recruitment
- Egypt
Study participating centre
Gesr Elnile street
Dakahleya Governorate
-
Egypt
Sponsor information
Hospital/treatment centre
Mitghamr City
Gesr Elnile Street
Dakahleya Governorate
35612
Egypt
| Phone | +20 (0)504906761 |
|---|---|
| healthresethics@deltahealth.online |
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | 01/02/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planning publication in a high impact peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Hala Mattout (HKMtoot@medicine.zu.edu.eg). The data available will be in the form of Excel sheets containing recorded pain scores, healing time and other outcome measures related to the research. Consents are obtained from patients. Data are shared with the statistical analysis team to obtain the results of the study |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 01/04/2021 | No | Yes | ||
| Participant information sheet | 01/04/2021 | No | Yes | ||
| Protocol file | 01/04/2021 | No | No | ||
| Results article | 12/01/2022 | 13/01/2022 | Yes | No |
Additional files
- ISRCTN21394752_PROTOCOL.doc
- Uploaded 01/04/2021
- ISRCTN21394752_PIS_Arabic.docx
- Uploaded 01/04/2021
- ISRCTN21394752_PIS_English.doc
- Uploaded 01/04/2021
Editorial Notes
13/01/2022: Publication reference added.
16/08/2021: The intention to publish date has been changed from 01/07/2021 to 01/02/2022.
01/04/2021: Uploaded protocol (not peer reviewed). The participant information sheet has been uploaded.
08/03/2021: Trial's existence confirmed by Delta Medical Center Research Ethics Committee.
