Limbal Astigmatic Keratotomy to Correct High Degrees of A... | NCT06179355

Studies
Limbal Astigmatic Keratotomy to Correct High Degrees of Astigmatism After Phacoemulsification

NCT06179355

Sponsor

Assiut University

Status

Completed

Last Update Posted

Mar 5, 2024Actual

Enrollment

40Actual

Phase

Not Applicable

Conditions

Astigmatism

Interventions

manual astigmatic keratotomy
femtosecond laser astigmatic keratotomy

Countries

Egypt

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

Oct 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2023Actual

Primary Completion Date

Jan 1, 2024Actual

Completion Date

Jan 1, 2024Actual

First Submitted Date

Dec 10, 2023

First Submission Date that Met QC Criteria

Dec 19, 2023

First Posted Date

Dec 21, 2023Actual

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 3, 2024

Last Update Posted Date

Mar 5, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Compare manually performed Astigmatic Keratotomy to femtosecond laser astigmatic keratotomy to manage corneal astigmatism more than three diopters after phacoemulsification.

Detailed Description

create circumferential corneal incisions, following the limbal curvature, at 1-1.5 mm anterior to the limbus, manually and by using femtosecond laser to correct corneal astigmatism more than three diopters after phacoemulsification.

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

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
manual Astigmatic Keratotomy	Experimental	manual limbal Astigmatic Keratotomy using a diamond knife group	Procedure: manual astigmatic keratotomy
femtosecond laser Astigmatic Keratotomy	Experimental	Femtosecond laser-guided astigmatic keratotomy group	Procedure: femtosecond laser astigmatic keratotomy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
manual astigmatic keratotomy	Procedure	manual astigmatic keratotomy using a diamond knife	manual Astigmatic Keratotomy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
astigmatism (Keratometric reading)	diopters of the astigmatism after the procedure measured by Pentacam	three month

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Possibility to have informed consent and attendance of all study visits.
Patients who have undergone conventional phacoemulsification at least one month ago.
Clear cornea.
Astigmatism more than 0.5 diopters.

Exclusion Criteria:

Corneal opacity.
History of corneal surgery.
Thin cornea.
Astigmatism equal to or less than 0.5 diopters.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ashraf Rashwan, MD	assiut univrsity	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Faculty of Medicine, Assiut University		Asyut			Egypt

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001251	Astigmatism

Ancestor Terms

ID	Term
D012030	Refractive Errors
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided