NCT06904560

Brief Summary

patients underwent phacoemulsification , balanced saline solution used during the operation will be at room temperature in one group and cool 2.7 c in the other group. the patients will be followed for 3 months after phacoemulsification regarding corneal endothelial cells and anterior segment inflammatory signs

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2025

Shorter than P25 for not_applicable

Status
not yet recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 24, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 1, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

April 1, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
Last Updated

April 1, 2025

Status Verified

March 1, 2025

Enrollment Period

2 months

First QC Date

March 24, 2025

Last Update Submit

March 28, 2025

Conditions

Corneal Diseases

Keywords

cornea, cataract

Outcome Measures

Primary Outcomes (1)

  • endothelial cell count

    3 months

Secondary Outcomes (1)

  • incidence of anterior segment inflammation

    3 months

Study Arms (2)

group 1

OTHER

patients underwent phacoemulsification , balanced saline solution at room temperature will be used for irrigation

Other: phacoemulsification

group 2

EXPERIMENTAL

patients underwent phacoemulsification , balanced saline solution with low (cold ) temperature will be used for irrigation

Other: phacoemulsification

Interventions

phacoemulsificationOTHER

one group with BSS at room temperature and the other group with cold BSS

group 1group 2

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients with cataract
  • more than 40 years
  • no glaucoma
  • no retinal abnormalities
  • no retinal abnormalities

You may not qualify if:

  • patients with corneal diseases patients less than 40 patients with previous eye surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Corneal DiseasesCataract

Interventions

Phacoemulsification

Condition Hierarchy (Ancestors)

Eye DiseasesLens Diseases

Intervention Hierarchy (Ancestors)

Cataract ExtractionRefractive Surgical ProceduresOphthalmologic Surgical ProceduresSurgical Procedures, OperativeUltrasonic Surgical Procedures

Central Study Contacts

Hany Mahmoud

CONTACT

01024368111drhanymahmoud@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor of ophthalmology

Study Record Dates

First Submitted

March 24, 2025

First Posted

April 1, 2025

Study Start

April 1, 2025

Primary Completion

June 1, 2025

Study Completion

July 1, 2025

Last Updated

April 1, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
6 months