Evaluation of Fibrin Matrix and Autologous Growth Factor Eye Drops Versus Amniotic Membrane Graft in Primary Pterygium Surgery Recurrence Prevention

The primary objective of this randomized clinical trial is to evaluate the **efficacy** of a fibrin membrane graft combined with eye drops concentrated in autologous growth factors in primary **pterygium** surgery. This is assessed by comparing the recurrence rate during the first postoperative year with that of an amniotic membrane graft. The clinical relevance of this study lies in its potential to improve surgical outcomes and reduce recurrence rates in patients undergoing pterygium surgery, thereby enhancing patient care and reducing the need for repeat surgeries.

Secondary objectives include: - Evaluating and comparing the epithelialization time after surgery in both techniques. - Assessing tissue healing in both techniques. - Evaluating the safety and surgical and postoperative complications of both techniques, including scleritis, persistent epithelial defect, graft retraction, graft loss, and intraocular hypertension secondary to corticosteroids. These secondary objectives aim to provide a comprehensive understanding of the comparative benefits and risks associated with each surgical technique, contributing to informed clinical decision-making.

The clinical trial focuses on evaluating the efficacy of fibrin membrane graft and eye drops of autologous growth factor concentrate in primary **pterygium** surgery. The study population includes both male and female participants aged between 20 and 60 years, with a diagnosis of primary pterygium, either unilateral or bilateral, characterized by fibrovascular proliferation growth. Participants are selected based on the presence of corneal invasion with a risk of visual impairment and/or ocular discomfort due to pterygium. The trial does not involve a vulnerable population. The sponsor has not provided information regarding the total number of participants. Lifestyle considerations such as diet, physical activity, or habits are not specified in the available data.

The clinical trial is designed as a **randomized**, double-blind, controlled study to evaluate the efficacy of a **fibrin membrane graft** with eye drops concentrated in autologous growth factors in primary **pterygium** surgery. The trial aims to compare this method with the use of an amniotic membrane graft, focusing on the recurrence rate during the first postoperative year. The study is expected to run from March 22, 2019, to March 22, 2026, with participant involvement lasting up to one year post-surgery.

Participants will undergo a series of study visits, beginning with an inclusion (screening) visit to confirm eligibility based on criteria such as age (20-60 years), presence of unilateral or bilateral primary pterygium with fibrovascular proliferation, and corneal invasion posing a risk of visual impairment or ocular discomfort. Following the initial surgery, follow-up visits are scheduled at one month, two months, three months, six months, and one year to monitor the recurrence of pterygium, defined as fibrovascular proliferation invading the corneal limbus and cornea.

The trial's primary endpoint is the recurrence rate of pterygium in both treatment groups, calculated as the number of recurrences per technique divided by the total number of surgeries performed with each method. Participants may be withdrawn from the study if they experience adverse effects or if they do not adhere to the study protocol. The trial is categorized as Phase IV with a low level of intervention, ensuring a focus on safety and efficacy in a real-world setting.

The clinical trial involves the use of **ENDORET-PRGF**, an experimental medication formulated as a **solution for injection**. The active substance in this product is a **fibrin matrix**, which is classified under the ATC code S01KX, indicating its use as an "Other Surgical Aid." The **fibrin matrix** is derived from a polymer origin. The medication is administered via injection, with a maximum daily dose of 1 unit and a total maximum dose of 1 unit over the treatment period. The maximum treatment period is set at 1 day. The product is not a pediatric formulation and is not classified as an orphan drug. The sponsor of this product is the Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau.

In addition to the experimental treatment, the study includes a comparator treatment involving an **amniotic membrane graft**. This comparator is used to evaluate the efficacy of the **fibrin membrane graft** and eye drops of autologous growth factor concentrate in primary pterygium surgery. The primary objective is to assess the recurrence rate during the first postoperative year. The study does not involve the use of a placebo or any other non-experimental treatments. Participant compliance with the dosing schedule will be monitored throughout the trial to ensure adherence to the protocol.

The efficacy of the treatment in this clinical trial will be assessed by evaluating the **recurrence rate** of primary pterygium following surgery. The trial aims to compare the efficacy of a fibrin membrane graft combined with eye drops concentrated in autologous growth factors against an amniotic membrane graft. The primary endpoint is defined as the recurrence rate, which is calculated by dividing the number of recurrences by the total number of surgeries performed with each technique. Recurrence is characterized by the reappearance of fibrovascular proliferation invading the corneal limbus and the cornea.

Measurements of recurrence will be conducted at multiple timepoints: one month, two months, three months, six months, and one year post-surgery. These follow-up assessments will allow for a comprehensive evaluation of the treatment's efficacy over the first postoperative year. The trial is designed to provide a robust comparison of the two surgical techniques in terms of their ability to prevent recurrence of pterygium.