Soft Contact Lens Fitting With Different Sagittal Height

• Sponsor: Tianjin Eye Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05962528
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 5
• Anticipated Duration (Months): 20
• Patients Per Site Per Month: 3

Study Details

Study Description

Brief Summary

To evaluate whether there is a difference in subjective and objective fit of soft lenses with different sagittal height

Condition or Disease	Intervention/Treatment	Phase
Myopia	Device: Soft lens	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Other
• Official Title: Soft Contact Lens Fitting With Different Sagittal Height
• Actual Study Start Date: Apr 1, 2023
• Actual Primary Completion Date: Jul 1, 2023
• Anticipated Study Completion Date: Dec 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Type 1 group Toric soft lens with high sagittal height	Device: Soft lens; Patients were randomly fitted with five different designs of soft lenses
Experimental: Type 2 group Toric soft lens with low sagittal height	Device: Soft lens; Patients were randomly fitted with five different designs of soft lenses
Experimental: Type 3 group Spherical soft lens with high sagittal height	Device: Soft lens; Patients were randomly fitted with five different designs of soft lenses
Experimental: Type 4 group Spherical soft lens with low sagittal height	Device: Soft lens; Patients were randomly fitted with five different designs of soft lenses
Placebo Comparator: Control group Traditional spherical soft lens	Device: Soft lens; Patients were randomly fitted with five different designs of soft lenses

Outcome Measures

Primary Outcome Measures

1. Subjective questionnaire [1 day (Once time after wearing the soft lens)]

   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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tianjin Eye Hospital	Tianjin		China	300020

Sponsors and Collaborators

• Tianjin Eye Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Tianjin Eye Hospital
• ClinicalTrials.gov Identifier: NCT05962528
• Other Study ID Numbers: KY2023024
• First Posted: Jul 27, 2023
• Last Update Posted: Jul 27, 2023
• Last Verified: Jul 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Seizures; Myopia

Study Results

No Results Posted as of Jul 27, 2023