NCT06694051

Brief Summary

Corneal refractive surgery is an effective way to correct refractive error. Modern corneal refractive surgery for the correction of myopia or hyperopia can achieve or close to the expected goal, but to eliminate astigmatism is always one of the major problems of corneal refractive surgery. The key point in the correction of astigmatism is that as a vector parameter, astigmatism has both magnitude and direction. The angle error may be caused by the rotation of the patient's head position and the involuntary rotation of eyes. Phototherapeutic keratectomy can precisely cut the corneal tissue, and is often used in clinic to remove corneal scars or repair corneal surface morphology. In this study, the excimer laser therapeutic keratectomy mode was used to achieve accurate marking of the axis of astigmatism by setting the treatment laser parameters. With the help of the static cyclotorsion of the eye, the precise treatment of astigmatism could realize.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2024

Geographic Reach
1 country

1 active site

Status
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

Study Start

First participant enrolled

October 1, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 15, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 19, 2024

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

November 19, 2024

Status Verified

November 1, 2024

Enrollment Period

1.2 years

First QC Date

November 15, 2024

Last Update Submit

November 15, 2024

Conditions

Astigmatism

Outcome Measures

Primary Outcomes (1)

  • refraction

    3 months

Study Arms (2)

ptk-group

EXPERIMENTAL
Procedure: marking

limbus-group

NO INTERVENTION

Interventions

markingPROCEDURE

axis marking

ptk-group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • at least 18 years old

You may not qualify if:

  • ocular disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tianjin Eye Hospital

Tianjin, Tianjin Municipality, 300020, China

RECRUITING

MeSH Terms

Conditions

Astigmatism

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Central Study Contacts

Wang

CONTACT

+86 022 27313336jiamei3536@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 15, 2024

First Posted

November 19, 2024

Study Start

October 1, 2024

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

November 19, 2024

Record last verified: 2024-11

Locations

CN(1)