A Trial Study on Evaluation the Safety and Efficacy of Rigid Breathable Scleral Contact Lenses (Model: KTSL ) of Astigmatism,Myopia or Hyperopia

Tianjin Eye Hospital1 site in 1 country176 target enrollmentNovember 1, 2022

ConditionsOcular Surface Disease Irregular Astigmatism Contact Lens Complication Corneal Astigmatism

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Ocular Surface Disease
Sponsor: Tianjin Eye Hospital
Enrollment: 176
Locations: 1
Primary Endpoint: Improvement of Best Corrected Vision Acuity
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

To evaluate the short-term efficacy and safety of scleral contact lens in the clinical treatment of patients with irregular astigmatism after corneal transplantation by analyzing ocular parameters and ocular surface conditions of patients after corneal transplantation.

Registry

clinicaltrials.gov

Start Date

November 1, 2022

End Date

December 1, 2024

Last Updated

2 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Tianjin Eye Hospital

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•1.8 ≤ age ≤ 55 years old;2.The diopter of one or both eyes is -25.00\~+25.00 D (including -25.00D and +25.00D), and corneal astigmatism caused by any reason (including keratoconus, irregular cornea) ≥0.75D.

Exclusion Criteria

•1.Patients who are judged by the investigator to be unsuitable for corneal endothelial cells;2.Dry eye ;3.Abnormal IOP ;4.Overt strabismus;5.Bacterial, fungal, viral and other active corneal infections;
•Being used may cause dry eyes or affect the eyeball or affect vision or affect the angle drugs such as membrane curvature;7.Corneal sensory, active corneal lesions;8.Conventional slit lamp microscopy and ophthalmoscopy, corneal diseases, iris cyclitis, chronic uveitis, cataract and vitreoretina related eye diseases disease or active and progressive disease;9.Other eye diseases: such as dacryocystitis, eyelid diseases and eyelid abnormalities or infections, eye muscle-related diseases, optic pathway diseases, glaucoma;10.Patients with systemic diseases that cause immunocompromise;History of allergy to contact lenses or contact lens care solution;11.History of allergy to contact lenses or contact lens care solution;12.Pregnant, lactating or planning to become pregnant in the near future;13.Subjects who are considered by the investigator to be unable to wear rigid contact lenses after comprehensively considering the corneal parameters, morphological characteristics and refractive examination results of the examination results;14.Those who have worn hard contact lenses within 30 days or soft hydrophilic contact lenses within 10 days;15.Those who participated in other drug clinical trials 3 months before screening and participated in other medical device clinical trials within 30 days;16.one-eyed patients;17.Those who have a strong sense of foreign body and cannot tolerate it and have poor compliance, and cannot be timely and regular to the medical institution for medical treatment as required;18.Other conditions judged by the investigator that the patient is not suitable for enrollment.

Outcomes

Primary Outcomes

Improvement of Best Corrected Vision Acuity

Time Frame: One year

The percentage of eyes with best corrected visual acuity improved by two lines or more (compared to best corrected visual acuity with glasses) or 5.0 or greater (standard logarithmic visual acuity chart) after 1 month ± 7 days of contact lens wear.