NCT07337070

Brief Summary

The goal of this clinical trial is to compare between two methods used in training residents on phacoemulsification. The residents were classified into two groups; the first group were trained on surgical steps in a chronological order, while the second groups in non-chronological order. The outcomes included surgical competency, success rate and incidence of complications.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
800

participants targeted

Target at P75+ for not_applicable

Timeline
1mo left

Started Jan 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress98%
Jan 2023Jun 2026

Study Start

First participant enrolled

January 10, 2023

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

January 4, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 13, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Last Updated

April 28, 2026

Status Verified

April 1, 2026

Enrollment Period

3.4 years

First QC Date

January 4, 2026

Last Update Submit

April 26, 2026

Conditions

Age-related Cataract

Keywords

PhacoemulsificationLearning curve in cataract surgeryTraining of ophthalmology residents

Outcome Measures

Primary Outcomes (1)

  • Success rate

    From enrollment till three months after the last surgery

Secondary Outcomes (1)

  • Incidence of complications

    From enrollment till 3 months after the last surgery

Study Arms (2)

Group A

ACTIVE COMPARATOR
Procedure: Chronological phacoemulsification training

Group B

ACTIVE COMPARATOR
Procedure: Non-Chronological phacoemulsification training

Interventions

Chronological phacoemulsification trainingPROCEDURE

Residents trained step-by-step in the natural order of phacoemulsification (incision, capsulorhexis, hydrodissection, phacoemulsification, irrigation/aspiration, IOL implantation, wound closure).

Group A
Non-Chronological phacoemulsification trainingPROCEDURE

Residents trained initially on selected steps (e.g., wound construction, IOL implantation, cortical cleanup) before progressing to more critical steps such as capsulorhexis and phacoemulsification

Group B

Eligibility Criteria

Age45 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients aged 45 years or more with age-related cataract, and prepared for phacoemulsification.

You may not qualify if:

  • Dense nuclear cataract grade IV or dense.
  • Intumescent cataract
  • Complicated and traumatic cataract
  • Zonular dehiscence
  • Poor pupillary dilatation
  • Coexisting ocular disorder (glaucoma, PEX, uveitis,central corneal opacity….)
  • Endothelial cell count 2000 or less
  • Axial length 21 mm or less, 26 mm or more.
  • Previous intraocular surgery
  • Poor vision in the fellow eye due to irreversible condition (6/60 or less)
  • Previous complicated cataract surgery in fellow eye.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag Faculty of Medicine

Sohag, Sohag Governorate, 82511, Egypt

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Ophthalmology

Study Record Dates

First Submitted

January 4, 2026

First Posted

January 13, 2026

Study Start

January 10, 2023

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Last Updated

April 28, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

All IPD will be available

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
By April 2026 and forever
Access Criteria
Will be uploaded at clinical trail registration record or upon request via email

Locations

EG(1)