NCT07769944

Brief Summary

This study aims to assess intraocular lens (IOL) tilt and decenteration by means of ultrasound biomicroscopy after phacoemulsification.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
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 Start

First participant enrolled

October 1, 2025

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

August 12, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 18, 2026

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Completed
Last Updated

August 18, 2026

Status Verified

August 1, 2026

Enrollment Period

1 year

First QC Date

August 12, 2026

Last Update Submit

August 12, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Measurement of intraocular lens tilt

    Measurement of intraocular lens (IOL) tilt. The intraocular lens (IOL) position was measured as the Anterior Chamber Depth (ACD), defined as the distance between the anterior border of the hyperreflective line marking the central posterior corneal surface and the anterior IOL optic surface at the centre of the pupillary space.

    Six months after surgery

Secondary Outcomes (1)

  • Measurement of intraocular lens decenteration

    Six months after surgery

Study Arms (2)

Group 1

Patients with implanted hydrophilic intraocular lens (IOL).

Device: Ultrasound biomicroscopy

Group 2

Patients with implanted hydrophobic intraocular lens (IOL).

Device: Ultrasound biomicroscopy

Interventions

Scanning is conducted with the non-dilated eye in a central position and the patient in the supine position. A drop of a topical anesthetic agent (benoxinate hydrochloride) is applied to both eyes.

Group 1Group 2

Eligibility Criteria

AgeUp to 45 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

A prospective, observational, hospital-based study which will be conducted in the Department of Ophthalmology, Sohag University Hospital, Egypt.

You may qualify if:

  • Both sexes.
  • Patients with senile cataract prepared for phacoemulsification and IOL implantation.

You may not qualify if:

  • Age \<45 years.
  • Complicated ataract.
  • Coexisting ocular disorders (Glaucoma, Pseudoexfoliation Syndrome, Sublaxation, Chronic Iridocyclitis).
  • Previous ocular surgery.
  • Complicated phacoemulsification.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag University

Sohag, Sohag Governorate, 82511, Egypt

RECRUITING

MeSH Terms

Interventions

Microscopy, Acoustic

Intervention Hierarchy (Ancestors)

MicroscopyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisUltrasonographyInvestigative Techniques

Central Study Contacts

Mennatullah A Farrag, MBBCH

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident of Ophthalmology, Faculty of Medicine, Sohag University, Egypt

Study Record Dates

First Submitted

August 12, 2026

First Posted

August 18, 2026

Study Start

October 1, 2025

Primary Completion

October 1, 2026

Study Completion

October 1, 2026

Last Updated

August 18, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will share

The data will be available upon a reasonable request from the corresponding author after the end of study for one year.

Shared Documents
STUDY PROTOCOL
Time Frame
After the end of study for one year.
Access Criteria
The data will be available upon a reasonable request from the corresponding author.

Locations