- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07605221
Nomogram for Astigmatism Correction of KLEx
Nomogram Optimization for Astigmatism Precision Correction of Corneal Refractive Correction
The goal of this clinical trial is to learn if nomogram could promote treatment outcomes in astigmatism correction. The main question it aims to answer is:
does the nomogram could promote treatment outcomes in astigmatism correction? If there is a comparison group: Researchers will compare non-nomogram adopted to see if the outcome acceptable.
Participants will ask to complete 3-month follow-up of manifest refraction and visual acuity test.
Study Overview
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jiamei Zhang
- Phone Number: 022-27305083
- Email: jiamei3536@163.com
Study Locations
-
-
Tianjin Municipality
-
Tianjin, Tianjin Municipality, China, 300000
- Recruiting
- Tianjin Eye Hospital
-
Contact:
- Yan Wang
- Phone Number: 022-27305083
- Email: wangyan7143@vip.sina.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- age ≥18 years; preoperative sphere -0.50 D to -10.00 D; preoperative cylinder -1.50 D to -5.00 D; stable refraction (±0.50 D) for 1 year; normal corneal topography; central corneal thickness >500 μm or predicted residual stromal bed >280 μm; intraocular pressure <21 mmHg
Exclusion Criteria:
- ocular or systematic disease
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: nomogram group
astigmatism was corrected with nomogram adjustment
|
nomogram was added to nomogram group
|
|
No Intervention: control group
astigmatism was corrected without nomogram adjustment
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
residual astigmstism
Time Frame: 3 months
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
visual acuity
Time Frame: 3 months
|
3 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Eye Diseases
- Refractive Errors
- Astigmatism
- Health Care Quality, Access, and Evaluation
- Investigative Techniques
- Epidemiologic Methods
- Diagnosis
- Health Care Evaluation Mechanisms
- Quality of Health Care
- Public Health
- Environment and Public Health
- Mathematical Concepts
- Statistics as Topic
- Prognosis
- Models, Theoretical
- Models, Statistical
- Nomograms
Other Study ID Numbers
- KY202632
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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