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Active, not recruitingNCT07287683Updated Dec 17, 2025

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

A Phase 1/2 interventional study of Topical Anaesthesia group and General Anaesthesia group in Topical Anaesthesia, General Anesthetic Drug Adverse Reaction and Cataract, sponsored by Alexandria University. Active, not recruiting at 1 site in Egypt. Open to participants aged 20 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-12-17.

Sponsored by Alexandria University · Phase 1/2, Interventional, and Other

From the registry’s dates

  • Primary completion was expected by Feb 2026, 7 months ago, but the record still lists the study as active, not recruiting.
  • Registered 5 months after the study started (first participant enrolled Apr 2025, registered Sep 2025).
Phase
Phase 1/2
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
20 Years to 70 Years
Sex
All
01

Study 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.

Read the detailed description

This prospective randomized controlled study will be carried out on 50 adult patients. Written informed consent will be taken from all prospective cases.

The cases will be selected having (ASA1), (ASA II) or (ASA III) physical status in the age range between 20 and 70 years old with cataract eye disease.

This study will be performed in Alexandria Main University Hospital, Egypt. Patients will be followed up at 24 hours, 1 week, and 6 weeks after surgery.

The following measurements will be recorded

  1. Pain will be assessed prior to surgery and after surgery using VAS score at 24 hours, 1 week, and 6 weeks after surgery.
  2. Need for analgesic intake after surgery will be assessed for the first 48 hours
  3. Complications after surgery as irritation, infection ,and foreign body sensation were assessed
  4. Patient satisfaction will be assessed.
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Conditions studied

  • Topical Anaesthesia
  • General Anesthetic Drug Adverse Reaction
  • Cataract

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03

In context

Cataract

1,701 studies on the registry are indexed under Cataract; 230 are open to participants now.

This study's enrollment of 50 is below the median of 80 across 1,155 interventional studies indexed under Cataract.

Browse Cataract studies →

Lead sponsor

Alexandria University is the lead sponsor of 569 studies on the registry; 125 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Phase
Phase 1 / Phase 2
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
50 participants (actual)

Study arms

  • Active comparator
    Group under general anesthesia for cataract surgery

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

    Drug: General Anaesthesia group

  • Active comparator
    Group under topical anaesthesia

    Patients will receive topical anaesthesia for cataract surgery

    Drug: Topical Anaesthesia group

Interventions

  • DrugTopical Anaesthesia group

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

    Also known as: Topical group

  • DrugGeneral Anaesthesia group

    General Anaesthesia will be given to this group undergoing cataract surgery

06

What researchers measure

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).

    Time frame: 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).

    Complications including hypotension, nausea and allergic reaction will be assessed after surgery and 24 hours later. satisfaction assessment will evaluate patient safety, pain control, comfort, nausea, interaction with the surgical team, willingness to repeat the anaesthetic, and relaxation during and after surgery. Patient satisfaction will be recorded at one week and six weeks postoperatively.

    Time frame: Up to 6 weeks

07

Study locations

1 site
  • Faculty of Medicine
    Alexandria, Egypt
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 17, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07287683
Lead sponsor
Alexandria University
Responsible party
radwa saber (Dr. Radwa Saber, lecturer of Anesthesiology, principal investigator, Alexandria University) — Principal investigator
First posted
Dec 17, 2025
Start date
Apr 2, 2025
Primary completion
Feb 20, 2026 (estimated)
Completion
Mar 15, 2026 (estimated)
Last update
Dec 17, 2025

Study contacts

Radwa S Raslan, PHD
principal investigator · AMUH

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

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