Clinical trial evaluation the effect of melatonin on analgesia and intraocular pressure in patient with cataract surgery under topical anesthesia.

The effect of melatonin on analgesia and intraocular pressure in cataract surgery with topical anesthesia.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20160430027677N8

Enrollment

120

Registered

2018-09-10

Start date

2016-09-21

Completion date

Unknown

Last updated

2018-10-11

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

Conditions

cataract. Senile incipient cataract

Interventions

Intervention 1: Intervention group will be received Melatonin 3 mg tablet oral placebo 60 minutes before surgery. Intervention 2: Control group will be received oral placebo 60 minutes before surgery.

Eligibility

Sex/Gender

All

Age

50 Years to 80 Years

Inclusion criteria

Inclusion criteria: Patients aged 50–80 years Patients with American Society of Anesthesiologists (ASA) physical status classification I–III Elective cataract surgery with intraocular lens implantation using phacoemulsification for the first time Surgery under topical anesthesia

Exclusion criteria

Exclusion criteria: Patients with sleep disorders; ;; ;;;; ; ; ; . Autoimmune disease Diabetes Depressive disorder Epilepsy Deafness Nystagmus Allergy to the study drugs Those who could not tolerate Shioetz tonometer during IOP measurement Ongoing treatment with opioids Analgesic treatment

Design outcomes

Primary

Measure	Time frame
Pain. Timepoint: Pain scores were will be measured and recorded 60 minutes before receiving premedication (T1) after receiving premedication during admission to the operating room (T2), during surgery (T3) and after the surgery, before being discharged from the recovery room (T4). Method of measurement: Verbal Pain Score.;Anxiety. Timepoint: Anxiety scores were will be measured and recorded 60 minutes before receiving premedication (T1) after receiving premedication during admission to the operating room (T2), during surgery (T3) and after the surgery, before being discharged from the recovery room (T4). Method of measurement: verbal anxiety score.	—

Measure

Time frame

Pain. Timepoint: Pain scores were will be measured and recorded 60 minutes before receiving premedication (T1) after receiving premedication during admission to the operating room (T2), during surgery (T3) and after the surgery, before being discharged from the recovery room (T4). Method of measurement: Verbal Pain Score.;Anxiety. Timepoint: Anxiety scores were will be measured and recorded 60 minutes before receiving premedication (T1) after receiving premedication during admission to the operating room (T2), during surgery (T3) and after the surgery, before being discharged from the recovery room (T4). Method of measurement: verbal anxiety score.

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Secondary

Measure	Time frame
Intraocular pressure. Timepoint: Intraocular pressure was only will be measured and recorded before premedication and after surgery in the recovery room. Method of measurement: Schiotz tonometer.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactShahryar Sane

Oroumia University of Medical Sciences

sanesh@umsu.ac.ir+98 44332234897

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026