Autologous Plasma Rich in Growth Factors for Severe Dry Eye Disease

Overview

The goal of this clinical trial is to evaluate the change in dry eye symptoms after the treatment with Plasma Rich in Growth Factors (PRGF) in patients with severe dry eye. The main question it aims to answer is: Are dry eye simptoms less after the treatment with PRGF? Researchers will compare standard topical treatment and PRGF with standard topical treatment and placebo to see if there is a difference in dry eye symptoms between arms. Secondary outcomes include changes in tear meniscus height, non invasive tear break-up time, conjunctival hyperemia, meibomian gland dropout and Ocular Staining Score (OSS) scale for corneal and conjunctival damage. Participants will be asked to use standard treatment and PRGF or placebo for 1 month.

Dry eye disease is a multifactorial condition that significantly affects patients' quality of life and, in many cases, shows a limited response to conventional topical treatment. PRGF has demonstrated anti-inflammatory and regenerative properties on the ocular surface, with favorable clinical outcomes in previous studies conducted primarily in foreign populations. However, there is limited evidence in Latin American populations, which justifies conducting this study. A prospective, randomized, masked study will be conducted, including 100 patients over 18 years of age with a diagnosis of severe dry eye disease. Participants will be randomly assigned in a 1:1 ratio to one of two treatment groups. The control group will receive standard topical treatment, including eyelid hygiene, artificial tears, cyclosporine, topical corticosteroids with a tapering regimen, and balanced saline solution as a placebo. The intervention group will receive the same standard treatment, with topical PRGF replacing the placebo, administered four times daily for a period of one month. All patients will be evaluated at a baseline visit and at a follow-up visit four weeks after treatment initiation. All patients will receive a follow-up telephone call two weeks after treatment initiation, and follow-up of each patient after completion of the study will be conducted according to the treating physician's judgment. The primary objective of the study is to determine the change in dry eye symptoms using the Ocular Surface Disease Index 6 (OSDI-6) questionnaire. Secondary objectives will include evaluation of changes in clinical signs of the ocular surface, including tear quantity and stability, conjunctival hyperemia, Meibomian gland dysfunction, corneal and conjunctival staining, as well as the occurrence of treatment-related adverse events. In both groups, the treating physician may add medications to the standard treatment at their discretion, as well as other therapies such as punctal plugs. Other non-invasive therapies, such as intense pulsed light, low-level light therapy, quantum molecular resonance, thermal pulsation therapy, or laser/plasma technology, may not be performed while the patient is participating in the study. The risks associated with the study are considered minimal and are primarily related to the blood draw required for PRGF preparation and the topical use of the product, which may result in mild and transient local adverse events. The study will be conducted in accordance with the principles of the Declaration of Helsinki, the Good Clinical Practice Guidelines, and Ministerial Agreement 206-2021 of the Ministry of Public Health and Social Assistance of Guatemala. All participants will provide written informed consent prior to enrollment in the study. The confidentiality of personal data will be ensured through the coding of information, and the study will have civil liability insurance covering any harm directly resulting from participation in the research.