Evaluation of Postoperative Pain in Cases Undergoing Cataract Surgery Under Topical Versus General Anesthesia

NCT07287683 | Active Not Recruiting Phase 1

• 1 other identifier: 0307211
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Comparison between cataract surgery under local versus general anesthesia regarding postoperative pain, complications and patient satisfaction and need for rescue analgesic intake after surgery The results will be followed up at 24 hrs, 1 week and after one and half month following the surgery.

Conditions

Topical Anaesthesia; General Anesthetic Drug Adverse Reaction; Cataract

Outcome Measures

Primary Outcomes (1)

• Post operative pain

  Postoperative pain will be assessed using the Visual Analogue Scale (VAS), ranging from 0 (no pain) to 10 (worst pain imaginable).

  At 24 hours, one week and 6 weeks following surgery

Secondary Outcomes (1)

• 1-complications after surgery 2-Patient satisfaction will be measured using the IOWA Satisfaction with Anaesthesia Scale (ISAS), which ranges from 6 (very satisfied) to 3 or less (dissatisfied).

  Up to 6 weeks

Study Arms (2)

Group under general anesthesia for cataract surgery

ACTIVE COMPARATOR

Patients undergoing cataract surgery will receive general Anaesthesia using intravenous injection and inhalational anaesthetics

Drug: General Anaesthesia group

Group under topical anaesthesia

ACTIVE COMPARATOR

Patients will receive topical anaesthesia for cataract surgery

Drug: Topical Anaesthesia group

Interventions

Topical Anaesthesia group DRUG

This group of patients will only receive topical anaesthesia for Cataract surgery

Also known as: Topical group

Group under topical anaesthesia

General Anaesthesia group DRUG

General Anaesthesia will be given to this group undergoing cataract surgery

Group under general anesthesia for cataract surgery

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Patients with unilateral cataract planned for surgery under topical or general anesthesia

You may not qualify if:

• patients under 20 or over 70 years old Eye infection Patient refusal

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Faculty of Medicine

Alexandria, Egypt

Location

MeSH Terms

Conditions

Cataract

Interventions

Population Groups

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Demography; Population Characteristics

Study Officials

• Radwa S Raslan, PHD

  AMUH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Radwa Saber, lecturer of Anesthesiology, principal investigator

Study Record Dates

• First Submitted: September 21, 2025
• First Posted: December 17, 2025
• Study Start: April 2, 2025
• Primary Completion: February 20, 2026
• Study Completion: March 15, 2026
• Last Updated: December 17, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)