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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: TCTR
Last refreshed on: 29 April 2024
Main ID:  TCTR20141110002
Date of registration: 10/11/2014
Prospective Registration: No
Primary sponsor: Ratchadaphiseksompot fund
Public title: The Innovation of CUTM-1 in Axis Measurement.
Scientific title: The Innovation of CUTM-1 in Axis Measurement.
Date of first enrolment: 09/09/2014
Target sample size:
Recruitment status: Completed
URL:  https://www.thaiclinicaltrials.org/show/TCTR20141110002
Study type:  Observational
Study design:  N/A  
Phase:  N/A
Countries of recruitment
Contacts
Name: Usanee -   Reinprayoon
Address:  - 10330 Bangkok Thailand
Telephone: 022564142
Email: Usaneer@gmail.com
Affiliation:  Department of ophthalmology, Faculty of Medicine, Chulalongkorn university
Name: Usanee -   Reinprayoon
Address:  - 10330 Bangkok Thailand
Telephone: 022564142
Email: Usaneer@gmail.com
Affiliation:  Department of ophthalmology, Faculty of Medicine, Chulalongkorn university
Key inclusion & exclusion criteria
Inclusion criteria: Healthy adult, age more than 20 years old, without ocular disease
Exclusion criteria: pregnancy, breastfeeding, allergy to topical anesthetic drug or sterile ink, and any risks

of infection (e.g. immunocompromised host)


Age minimum: 20 Years
Age maximum: 120 Years
Gender: Both
Health Condition(s) or Problem(s) studied
corneal axis
axis marking method
astigmatic corneal marker
axis misalignment
Toric marker in cataract surgery for astigmatic correction
corneal axis
axis marking method
astigmatic corneal marker
axis misalignment
Intervention(s)
The CUTM-1 application,The slit lamp marking technique
Other,Other
The photograph was taken via the CUTM-1 application on mobile phone (iPhone5S, Apple, USA) which was attached on right slit-lamp eyepiece , volunteer was in upright position with the fellow eye fixed on distant target. The assigned axis was marked and saved on iPhone.,Slit-lamp photography (SL-D7 with DC-3 integrated digital camera, Topcon Corporation, Tokyo, Japan) was taken in upright position with the fellow eye fixed on distant target. All pictures were captured under same setting, which were diffuse illumination, 45 degree deviation of illuminating arm from the midline to temporal side and 16x optical magnification. A standard slit-lamp marking technique was performed using a sterile ink (Securline® Surgical Skin Marker, Aspen Medical Europe Ltd., Redditch, UK) to mark 0-180 degree reference point at the limbus in upright position and mark assigned axis using Mendez ring in supine position under surgical microscope. Then, the second photograph was taken.
Primary Outcome(s)
Horizontal deviation None Degree,Decentration None Millimeter,Axis deviation None Degree,Total axis deviation None Degree
Secondary Outcome(s)
None None None
Secondary ID(s)
Source(s) of Monetary Support
None
Secondary Sponsor(s)
Ethics review
Status: Submitted, approved
Approval date:
Contact:
Research_affair@gmail.com
Med Chula IRB
022564493 Ext. -
Research_affair@gmail.com
Results
Results available:
Date Posted:
Date Completed: 09/10/2014
URL:
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