Evaluation of the Safety and Efficacy of Rigid Breathable Scleral Contact Lenses for the Correction of Ametropia

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

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.

Study Overview

• Status: Recruiting
• Conditions: Corneal Astigmatism; Ocular Surface Disease; Contact Lens Complication; Irregular Astigmatism

• Study Type: Observational
• Enrollment (Estimated): 176

Contacts and Locations

• Study Contact: Name: Xinyu Yang; Phone Number: 022-27313336; Email: yxydoctor0725@163.com

Study Locations

• China
  • Tianjin
    • Tianjin, Tianjin, China
      • Recruiting
      • Tianjin Eye Hospital
      • Contact: yan wang, director; Phone Number: +862227313336; Email: wangyan7143@vip.sina.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Patients with corneal astigmatism

Description

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;6. 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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
scleral contact lenses group; The selected patients were equipped with scleral contact lenses to evaluate their best corrected visual acuity, refraction, ocular surface condition, and fitting status of contact lenses.
RGP group; The selected patients were equipped with RGP to evaluate their best corrected visual acuity, refraction, ocular surface condition, and fitting status of contact lenses.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement of Best Corrected Vision Acuity	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.	One year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Best Corrected Visual Acuity and Refraction with Contact Lenses	Contact lenses for best corrected visual acuity. List the visual acuity of wearing glasses 7 days±3 days,1 month±7 days, and 3 months±14 days after wearing glasses. To provide the statistical analysis results of spectacle visual acuity in the experimental group and the control group;; Diopter. The diopters of 7 days±3 days,1 month±7 days, and 3 months±14 days after wearing glasses were listed, and the results of diopter analysis in the experimental group and the control group were provided.	One year

Collaborators and Investigators

• Sponsor: Tianjin Eye Hospital
• Investigators: Study Chair: Yan Wang, Prof, Tianjin Eye Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2022
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: February 5, 2024
• First Submitted That Met QC Criteria: February 5, 2024
• First Posted (Actual): February 13, 2024

Study Record Updates

• Last Update Posted (Actual): February 13, 2024
• Last Update Submitted That Met QC Criteria: February 5, 2024
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Ocular Surface Disease; Irregular Astigmatism; Corneal Astigmatism; Contact Lens Complication
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Astigmatism
• Other Study ID Numbers: zhangyi2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No