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Analgesic eye drops for pain control after a refractive procedure

The use of topical nalbuphine in different concentrations to control pain after photorefractive keratectomy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN21394752
Enrollment
200
Registered
2021-03-08
Start date
2019-07-01
Completion date
Unknown
Last updated
2022-01-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain following photorefractive keratectomy procedure Surgery

Interventions

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 concent

Sponsors

Delta Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Pain measured using a numeric rating scale (recording the maximum pain level) in the first 3 postoperative days

Secondary

MeasureTime frame
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

Countries

Egypt

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 19, 2026