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Efficacy and safety assessment of rigid scleral lens for correction of corneal irregular astigmatism combined with myopia or hyperopia- a prospective, multi-center, single-treatment arm, clinical trial

Efficacy and safety assessment of rigid scleral lens for correction of corneal irregular astigmatism combined with myopia or hyperopia- a prospective, multi-center, single-treatment arm, clinical trial

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200063610
Enrollment
Unknown
Registered
2022-09-13
Start date
2022-09-13
Completion date
Unknown
Last updated
2023-04-17

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

Conditions

corneal irregular astigmatism combined with myopia or hyperopia

Interventions

Scleral lens group:Wear of scleral lens

Sponsors

Eye Hospital of Wenzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Aged between 18 to 65 tears (inclusive), male or female 2. Having corneal irregular astigmatism combined with myopia or hyperopia 3. Willing to comply the examination and follow-up procedures

Exclusion criteria

Exclusion criteria: 1. Best corrected vison acuity to be 4.9 or better 2. Using drugs that may affect the vison or corneal curvature 3. Suffering from various infectious ocular diseases, including but not limited to ocular infections of the cornea, conjunctiva, or eyelids Diseases, glaucoma; those who cannot wear hard scleral contact lenses as judged by an ophthalmologist. 4. Have systemic diseases that may affect the eyes (such as acute and chronic sinusitis, diabetes, Down syndrome Symptoms, rheumatoid arthritis, mental illness, etc.), have diseases that an ophthalmologist determined to be unsuitable to wear scleral contact lenses. 5. Have a history of contact lens allergy or allergy of contact lens care solutions. 6. Those who do not have the good hygiene to wear scleral lenses. 7. Pregnant women, lactating women or those who plan to have baby recently. 8. Those who have worn rigid gas permeable contact lenses or orthokeratology lenses within the past 30 days. 9. Those who have undergone corneal cross-linking surgery within the past 3 months. 10. Within 3 months after the last suture removal of corneal transplantation. 11. Patients with advanced keratoconus requiring surgical treatment within 3 months. 12. Those who have participated in or undergoing treatment in drug clinical trials within 3 months or have participated in or are participating in medical device clinical trials within 30 days. 13. Other circumstances judged by the investigator to be inappropriate to participate in the trial

Design outcomes

Primary

MeasureTime frame
Best corrected vision acuity;

Countries

China

Contacts

Public ContactJiang Jun, Chen Zhi
jjhsj@hotmail.com13506511080 / 13761681740

Outcome results

None listed

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