Limbal Astigmatic Keratotomy to Correct High Degrees of Astigmatism After Phacoemulsification

March 3, 2024 updated by: Ashraf Rashwan, Assiut University

Comparison Between Manual Limbal Astigmatic Keratotomy and Femtosecond Laser-guided Limbal Astigmatic Keratotomy for Correction of Astigmatism More Than Three Diopters After Phacoemulsification

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Assiut, Egypt
        • Faculty of Medicine, Assiut University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: manual Astigmatic Keratotomy
manual limbal Astigmatic Keratotomy using a diamond knife group
Procedure: manual astigmatic keratotomy
manual astigmatic keratotomy using a diamond knife
Experimental: femtosecond laser Astigmatic Keratotomy
Femtosecond laser-guided astigmatic keratotomy group
Procedure: femtosecond laser astigmatic keratotomy
astigmatic keratotomy using femtosecond lase

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Principal Investigator: Ashraf Rashwan, MD, assiut univrsity

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2023

Primary Completion (Actual)

January 1, 2024

Study Completion (Actual)

January 1, 2024

Study Registration Dates

First Submitted

December 10, 2023

First Submitted That Met QC Criteria

December 19, 2023

First Posted (Actual)

December 21, 2023

Study Record Updates

Last Update Posted (Estimated)

March 5, 2024

Last Update Submitted That Met QC Criteria

March 3, 2024

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1727367365

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Astigmatism

Clinical Trials on manual astigmatic keratotomy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Burkina Faso

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe