Sublingual melatonin before cataract surgery in older adults
Official title: The Use of Sublingual Melatonin Premedication in Geriatric Cataract Surgery
Run by Al-Azhar University · NCT07036367 · Data updated 2026-11-12
This study will test whether taking sublingual melatonin before cataract surgery helps adults aged 60 and older feel less anxious and sedated while remaining safe.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 60 Years and up |
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | Al-Azhar University Academic / other |
| Locations | 2 sites (Cairo, Egypt and 1 other locations) |
| Status | Recruiting |
| Started | September 1, 2025 |
| Main results expected | May 15, 2026 |
| Study ends | June 15, 2026 |
| Registry record updated | January 7, 2026 |
| Trial ID | NCT07036367 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 60 or older, ASA I–III, scheduled for unilateral cataract surgery under local anesthesia who are not taking chronic sedatives and can complete study questionnaires.
✕Probably not a fit
Patients with a known melatonin allergy, chronic use of sedatives or hypnotics, sleep or psychiatric disorders, significant communication-impairing sensory deficits, emergency surgeries, or anticipated intraoperative complications are unlikely to benefit or are excluded.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Adults aged 60 and older scheduled for unilateral cataract surgery under local anesthesia will receive either sublingual melatonin or a matching placebo before the procedure. Eligible participants are ASA physical status I–III and must be able to complete study questionnaires. The trial will record patient-reported anxiety and sedation, as well as objective hemodynamic measures like blood pressure and heart rate and any adverse events. Results will compare anxiety relief, sedation levels, and safety between the melatonin and placebo groups.
Why it matters
Potential benefit: If effective, melatonin could lower preoperative anxiety and reduce the need for stronger sedatives, improving comfort and hemodynamic stability for older cataract patients.
How similar studies have gone: Previous small trials in other surgical settings have suggested melatonin can reduce preoperative anxiety with a favorable safety profile, but its specific use in geriatric cataract surgery is not well established.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * • Age ≥ 60 years * American Society of Anesthesiologists (ASA) physical status I-III * Scheduled for unilateral cataract surgery under local anesthesia * Ability to understand and complete study-related questionnaires Exclusion Criteria: * • Known allergy or hypersensitivity to melatonin * Chronic use of sedatives, hypnotics, or anxiolytics * History of sleep disorders or psychiatric illness * Visual or hearing impairment that would hinder communication * Emergency surgery or anticipated intraoperative complications
Where it's running
-
Al-Azhar University
Baghdad, Baghdad Governorate, Iraq Recruiting -
Al-Azhar University
Cairo, Egypt, Egypt Not yet recruiting
Study contacts
- Principal investigator: Neveen A Kohaf, PhD — Al-Azhar University
- Study coordinator: Neveen A Kohaf, PhD
- Email: nevenabdo@azhar.edu.eg
- Phone: +201060383012
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.