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

D&V FARMA srl20 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Corneal Epithelial Wound Healing

Interventions

CXC-SPDEVICE

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

CTRLDEVICE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

San Giovanni-Addolorata Hospital

Rome, Italy

Outcomes

Primary Outcomes

Corneal re-ephitalization

To evaluate and follow the corneal re-ephitalization process a topograph measuring epithelium thickness will be used.

Time frame: 2 WEEKS

Data from ClinicalTrials.gov

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