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Validation of the efficacy and safety of scleral contact lens in clinical application

Validation of the efficacy and safety of scleral contact lens in clinical application

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500109533
Enrollment
Unknown
Registered
2025-09-19
Start date
2025-10-05
Completion date
Unknown
Last updated
2025-09-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Keratoconus, corneal trauma, refractive error, corneal degeneration, dry eye, amblyopia, keratitis

Interventions

Fit the Epco scleral endoscope group :NA
Fit the Aiconfi scleral lens group:NA
Fit the CS scleral lens group :NA

Sponsors

Bejing Tongren Hospital, Capital Medical Uniersity
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1.Patient age: 18 years old to 65 years old, gender not limited; 2.Indications for scleral endoscopy fitting caused by various factors; 3.The refractive error is within ±25.00D (including ±25.00D); 4.Rigid scleral contact lenses have been successfully fitted and there is a follow-up visit record of wearing the lenses for at least 3 months.

Exclusion criteria

Exclusion criteria: 1.Suffer from ocular infectious diseases; 2.Have glaucoma; 3.There are severe red eyes or eye irritation symptoms; 4.Allergic reactions occur on the ocular surface and ocular adnexa, and may be exacerbated by wearing lenses or using lens care solutions; 5.Patients who have been allergic to rigid contact lenses or rigid contact lens care products in the past; 6.Patients who are currently using or need to use drugs that may cause dry eyes or affect vision and corneal curvature during research; 7.Patients who have worn rigid breathable contact lenses for orthokeratology within one month in the past; 8.Those who have participated in clinical trials of other drugs or medical devices within one month prior to the screening (except for registered studies); 9.Pregnant women, lactating women or those who are planning to get pregnant in the near future; 10.Other circumstances under which the researcher judged that the patient was not suitable for inclusion.

Design outcomes

Primary

MeasureTime frame
Intraocular pressure;Eye condition;The best corrected visual acuity with scleral glasses;Best corrected visual acuity of frame glasses;Corneal endothelial cells;Fundus;

Countries

China

Contacts

Public ContactJieYing

Bejing Tongren Hospital, Capital Medical Uniersity

jie_yingcn@aliyun.com+86 13693572296

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026