NCT06179355

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

October 1, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 10, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 21, 2023

Completed
11 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2024

Completed
Last Updated

March 5, 2024

Status Verified

October 1, 2023

Enrollment Period

3 months

First QC Date

December 10, 2023

Last Update Submit

March 3, 2024

Conditions

Astigmatism

Outcome Measures

Primary Outcomes (1)

  • astigmatism (Keratometric reading)

    diopters of the astigmatism after the procedure measured by Pentacam

    three month

Study Arms (2)

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

manual astigmatic keratotomyPROCEDURE

manual astigmatic keratotomy using a diamond knife

manual Astigmatic Keratotomy
femtosecond laser astigmatic keratotomyPROCEDURE

astigmatic keratotomy using femtosecond lase

femtosecond laser Astigmatic Keratotomy

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine, Assiut University

Asyut, Egypt

Location

MeSH Terms

Conditions

Astigmatism

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Study Officials

  • Ashraf Rashwan, MD

    assiut univrsity

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

December 10, 2023

First Posted

December 21, 2023

Study Start

October 1, 2023

Primary Completion

January 1, 2024

Study Completion

January 1, 2024

Last Updated

March 5, 2024

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)