Back to resultsSoft Contact Lens Fitting With Different Sagittal Height
Primary Purpose
Myopia
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Soft lens
Sponsored by
About this trial
This is an interventional other trial for Myopia
Eligibility Criteria
Inclusion Criteria: Age more than 18 years No active eye disease 5 soft lenses for the experiment can be successfully worn and all examinations can be completed as required Exclusion Criteria: Active eye disease BCVA less than 20/25 Those who are too small or tight eyelids are not suitable for wearing soft lenses
Sites / Locations
- Tianjin Eye HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
Type 1 group
Type 2 group
Type 3 group
Type 4 group
Control group
Arm Description
Toric soft lens with high sagittal height
Toric soft lens with low sagittal height
Spherical soft lens with high sagittal height
Spherical soft lens with low sagittal height
Traditional spherical soft lens
Outcomes
Primary Outcome Measures
Subjective questionnaire
The subjective questionnaire is a visual quality questionnaire developed by combining previous research and clinical symptoms, including whether there is foreign body sensation, pain, dry eyes, etc.The score ranges from 0 to 4, with the higher the score, the more obvious the symptoms
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05962528
Brief Title
Soft Contact Lens Fitting With Different Sagittal Height
Official Title
Soft Contact Lens Fitting With Different Sagittal Height
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2023 (Actual)
Primary Completion Date
July 1, 2023 (Actual)
Study Completion Date
December 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tianjin Eye Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To evaluate whether there is a difference in subjective and objective fit of soft lenses with different sagittal height
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Type 1 group
Arm Type
Experimental
Arm Description
Toric soft lens with high sagittal height
Arm Title
Type 2 group
Arm Type
Experimental
Arm Description
Toric soft lens with low sagittal height
Arm Title
Type 3 group
Arm Type
Experimental
Arm Description
Spherical soft lens with high sagittal height
Arm Title
Type 4 group
Arm Type
Experimental
Arm Description
Spherical soft lens with low sagittal height
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
Traditional spherical soft lens
Intervention Type
Device
Intervention Name(s)
Soft lens
Intervention Description
Patients were randomly fitted with five different designs of soft lenses
Primary Outcome Measure Information:
Title
Subjective questionnaire
Description
The subjective questionnaire is a visual quality questionnaire developed by combining previous research and clinical symptoms, including whether there is foreign body sensation, pain, dry eyes, etc.The score ranges from 0 to 4, with the higher the score, the more obvious the symptoms
Time Frame
1 day (Once time after wearing the soft lens)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age more than 18 years
No active eye disease
5 soft lenses for the experiment can be successfully worn and all examinations can be completed as required
Exclusion Criteria:
Active eye disease
BCVA less than 20/25
Those who are too small or tight eyelids are not suitable for wearing soft lenses
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tiejing Sun, MD
Phone
+8627306525
Email
suntiejing0109@163.com
Facility Information:
Facility Name
Tianjin Eye Hospital
City
Tianjin
ZIP/Postal Code
300020
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tiejing Sun, MD
Phone
+8627306525
Email
suntiejing0109@163.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Soft Contact Lens Fitting With Different Sagittal Height
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