Skip to content

Efficacy and safety of scleral lens in the treatment of irregular astigmatism caused by moderate to severe dry eye

Efficacy and safety of scleral lens in the treatment of irregular astigmatism caused by moderate to severe dry eye

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400094029
Enrollment
Unknown
Registered
2024-12-16
Start date
2023-12-13
Completion date
Unknown
Last updated
2025-01-06

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

Conditions

Dry eye

Interventions

Experimental Group:Wearing scleral lens

Sponsors

The First Affiliated Hospital of the Army Medical University of the People's Liberation Army
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1) Aged between 18 and 70, voluntarily participate in this clinical study, and sign the informed consent form. 2) Irregular astigmatism caused by moderate to severe dry eyes is not effective after conventional treatment, the specific manifestation is: after 2 weeks to 1 month of conventional treatment, there is no significant improvement in visual quality and subjective symptom scores of dry eye, as well as objective examination results. 3) Presenting with clinical symptoms and signs of dry eye, and the clinical examination meets the diagnostic criteria for moderate and severe dry eye in the "Chinese Dry Eye Expert Consensus: Definition and Classification (2020)": A.Moderate dry eye: Slit-lamp examination shows corneal damage involving no more than 2 quadrants and/or corneal fluorescein staining with >=5 spots and =2 seconds. B. Severe dry eye: Slit-lamp examination shows corneal damage involving more than 2 quadrants and/or corneal fluorescein staining with>=30 spots, with a tear breakup time (BUT) =23 points.

Exclusion criteria

Exclusion criteria: 1) Patients with fungal, bacterial or viral keratoconjunctivitis are clinically suspected to be active. 2) Patients with a history of eye surgery within the last 3 months or who plan to have eye surgery during the study period. 3) Patients who have previously undergone treatment with scleral lenses to correct irregular astigmatism. 4) Known allergic history of scleroscope materials used in this study. 5) Patients who, in the opinion of the physician, are not suitable for participation in the study.

Design outcomes

Primary

MeasureTime frame
Ocular Surface Disease Index Scale(OSDI) score;

Secondary

MeasureTime frame
Ocular surface score;Tear secretion;Tear break up time;Lipid layer thickness;Meibomian gland score;Central corneal thickness;Endothelial cell density;Aberration;

Countries

China

Contacts

Public ContactYang Yulil

The First Affiliated Hospital of the Army Medical University of the People's Liberation Army

yangyuli1023@tmmu.edu.cn+86 150 8684 2405

Outcome results

None listed

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