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Therapeutic effect of individualized sclera contact lens based on 3 D bio-printing technique in moderate to severe dry eyes patients: a randomized controlled trial.

Therapeutic effect of individualized sclera contact lens based on 3 D bio-printing technique in moderate to severe dry eyes patients

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000035306
Enrollment
Unknown
Registered
2020-08-07
Start date
2020-10-01
Completion date
Unknown
Last updated
2020-08-10

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:Wear scleral contact lens

Sponsors

The Huadong Hospital affliated to Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1) Patients between the ages of 18 and 60; 2) Tear film breakup time (TBUT) < 5 s; 3) Schirmer I test <= 5 mm/5min; without surface anesthesia; 4) Corneal fluorescein staining score greater than 2 points; 5) Subjects are fully familiar with the study and voluntarily participate in this clinical trial and sign informed consent.

Exclusion criteria

Exclusion criteria: 1) Patients with acute inflammatory infection in ocular horn conjunctiva; 2) Dry-eye patients who had received subtear embolization, tarsal gland thermal pulse and optimized intense pulse light in half a year; 3) Autoimmune disease patients; 4) There are other eye diseases need long-term eye drops patients, such as glaucoma, anterior uveitis and other diseases; 5) Patients with obvious allergic constitution; 6) Is taking oral hormone or receiving eye hormone treatment patients; 7) Pregnant or lactating women who plan to conceive in the near future; 8) Patients in other clinical trials within the last 3 months; 9) Patients with progressive severe disease (cancer); 10) Failure to follow up on schedule or to cooperate with researchers.

Design outcomes

Primary

MeasureTime frame
TBUT;

Secondary

MeasureTime frame
OSDI Questionnaire;SChirmer test;Lachrymal height;corneal fluorescein staining;Conjunctival lisamine green;osmotic pressure of tears;Corneal topography;Refraction;lipid;

Countries

China

Contacts

Public ContactWu Rong

The Huadong Hospital affliated to Fudan University

wurong0483@yahoo.com86 13636624399

Outcome results

None listed

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