The Relation Between BSS Solution Temperature and Endothe... | NCT06904560

Studies
The Relation Between BSS Solution Temperature and Endothelial Cells and Post Phaco Discomfort

NCT06904560

Sponsor

Sohag University

Status

Not yet recruiting

Last Update Posted

Apr 1, 2025Actual

Enrollment

40Estimated

Phase

Not Applicable

Conditions

Corneal Diseases

Interventions

phacoemulsification

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2025

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2025Estimated

Primary Completion Date

Jun 1, 2025Estimated

Completion Date

Jul 1, 2025Estimated

First Submitted Date

Mar 24, 2025

First Submission Date that Met QC Criteria

Mar 28, 2025

First Posted Date

Apr 1, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 28, 2025

Last Update Posted Date

Apr 1, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
phacoemulsification	Other	one group with BSS at room temperature and the other group with cold BSS	group 1 group 2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
endothelial cell count		3 months

Secondary Outcomes

Measure	Description	Time Frame
incidence of anterior segment inflammation	incidence of anterior segment inflammation including conjunctival hypremia or corneal edema	3 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Hany Mahmoud	Contact	01024368111		drhanymahmoud@gmail.com

Overall Officials

Not provided

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Not provided

Types

Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)

Time Frame

6 months

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003316	Corneal Diseases
D002386	Cataract

Ancestor Terms

ID	Term
D005128	Eye Diseases
D007905	Lens Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D018918	Phacoemulsification

Ancestor Terms

ID	Term
D002387	Cataract Extraction
D054140	Refractive Surgical Procedures
D013508	Ophthalmologic Surgical Procedures
D013514	Surgical Procedures, Operative

Browse Leaves

Not provided

Browse Branches

Not provided