Cross-linked CMC and Silk Proteins in Corneal Re-epithelization

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-01-01

Study Completion Date

2024-06-01

Brief Summary

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Data analyses and revision of the corneal re-epithelization in patients who underwent either PRK (Photorefractive Keratectomy), CXL (Corneal Cross-Linking), PTK (phototherapeutic keratectomy), or experienced a corneal abrasion. A novel ophthalmic solution containing cross-linked CMC (CX-CMC) and Silk Proteins (SP) has been made available on the market. Both molecules have been widely studied for their wound healing properties in the ophtalmic field. This new ophthalmic solution is the first on the market formulated with a CX-CMC and SP.

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Detailed Description

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Conditions

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Corneal Epithelial Wound Healing

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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CXC-SP

subjects who underwent either PRK, CXL, PTK or experienced a corneal abrasion treated with a standard therapy plus silk protein and CX-CMC-based eye drops.

CXC-SP

Intervention Type DEVICE

Standard therapy plus sterile Isotonic ophthalmic solution based on CX-CMC and silk protein, istilled six time a day until complete healing.

CTRL

subjects who underwent either PRK , CXL , PTK , or experienced a corneal abrasion. The subjects were treated with the standard therapy only.

CTRL

Intervention Type DEVICE

Standard therapy plus sterile ophtalmic isotonic solution for six time a day until complete healing.

Interventions

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CXC-SP

Standard therapy plus sterile Isotonic ophthalmic solution based on CX-CMC and silk protein, istilled six time a day until complete healing.

Intervention Type DEVICE

CTRL

Standard therapy plus sterile ophtalmic isotonic solution for six time a day until complete healing.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patients who had undergone surgical procedures involving de-epithelialization, which included CXL, PRK, and PTK, as well as those with a first diagnosis of corneal abrasion

Exclusion Criteria

* patients with known allergies or hypersensitivity to any components of the tested formulations or standard therapies, or those requiring different treatments compared to the rest of the study population

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No