Clinical trial Recruiting at 1 site Phase 4 Interventional Ages 60 and up

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

PhasePhase 4
Study typeInterventional
Ages60 Years and up
SexAll
Enrollment60 (estimated)
SponsorAl-Azhar University
Academic / other
Locations2 sites (Cairo, Egypt and 1 other locations)
StatusRecruiting
StartedSeptember 1, 2025
Main results expectedMay 15, 2026
Study endsJune 15, 2026
Registry record updatedJanuary 7, 2026
Trial IDNCT07036367 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

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.