Study on Fibrin Matrix and Autologous Growth Factor Eye Drops for Pterygium Surgery Patients

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What is this study about?

This clinical trial is focused on studying a condition called pterygium, which is a growth of tissue on the white part of the eye that can extend onto the cornea. The study aims to compare two different treatments used during surgery for this condition. One treatment involves using a fibrin membrane graft combined with eye drops that are rich in the patient’s own growth factors. The other treatment uses an amniotic membrane graft, which is a type of tissue graft taken from the innermost layer of the placenta.

The purpose of the study is to evaluate how effective these treatments are in preventing the return of pterygium after surgery. Participants in the study will undergo surgery for pterygium and will receive one of the two treatments. The study will monitor the recurrence of the condition over the course of one year after the surgery. Follow-up visits will occur at one month, two months, three months, six months, and one year to check for any signs of the pterygium returning.

The study will help determine which treatment is more effective in reducing the recurrence of pterygium, providing valuable information for future treatment options. Participants will contribute to advancing medical knowledge in the management of this eye condition. The trial is expected to continue until 2026, allowing for comprehensive data collection and analysis.

1 initial surgery

The trial begins with a surgical procedure to remove the pterygium, which is a growth of tissue on the eye. This surgery is necessary to address the risk of visual impairment or discomfort.

During the surgery, a graft is applied. This graft can be either a fibrin membrane with eye drops concentrated in autologous growth factors or an amniotic membrane. The choice of graft is determined by the study protocol.

2 postoperative care

After the surgery, follow-up care is essential to monitor healing and detect any recurrence of the pterygium.

The follow-up schedule includes visits at one month, two months, three months, six months, and one year after the surgery. During these visits, the eye is examined for any signs of fibrovascular proliferation, which indicates recurrence.

3 medication administration

As part of the trial, eye drops containing autologous growth factors may be administered. These drops are derived from the patient’s own blood and are used to promote healing and reduce the risk of recurrence.

The dosage and frequency of the eye drops are determined by the study protocol and are administered as instructed by the healthcare provider.

4 evaluation of outcomes

The primary outcome of the trial is the recurrence rate of the pterygium. This is assessed by comparing the number of recurrences in patients who received the fibrin membrane graft with those who received the amniotic membrane graft.

The evaluation of recurrence is based on the appearance of fibrovascular proliferation invading the corneal limbus and the cornea during the follow-up visits.

Who Can Join the Study?

The patient must have a condition called primary pterygium, which can be in one or both eyes. This condition involves the growth of tissue on the eye.
The patient should be between the ages of 20 and 60 years old.
The pterygium must be growing onto the cornea, which is the clear front part of the eye, and there should be a risk of it affecting vision or causing discomfort in the eye.
Both male and female patients can participate.
The study does not include vulnerable populations, meaning it is not designed for groups that might need special protection.

Who Cannot Join the Study?

Patients with any other eye condition that might interfere with the study results.
Individuals who have had previous eye surgery that could affect the study outcomes.
People with allergies to any of the substances used in the study.
Participants who are unable to follow the study procedures or attend follow-up visits.
Individuals with a history of certain medical conditions that could impact the study, such as uncontrolled diabetes or autoimmune diseases.
Pregnant or breastfeeding women, as the study may not be safe for them.
Patients currently participating in another clinical trial.
Anyone who has used certain medications that might interfere with the study results.
Individuals with a history of drug or alcohol abuse that could affect their ability to participate in the study.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Houddvys Dg Lj Srlws Cprl I Sqqz Pcq	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Spain	Recruiting	22.03.2019

Trial locations

Fibrin Membrane Graft is a type of surgical treatment used in eye surgery, specifically for primary pterygium. It involves using a membrane made from fibrin, a protein involved in blood clotting, to help cover and protect the area where the pterygium was removed. This graft aims to reduce the chance of the pterygium coming back after surgery.

Eye Drops Concentrated in Autologous Growth Factors are special eye drops made from the patient’s own blood. These drops are rich in growth factors, which are natural substances that help promote healing and tissue repair. In this trial, they are used after pterygium surgery to help the eye heal better and reduce the risk of the pterygium returning.

Amniotic Membrane Graft is another surgical treatment option for primary pterygium. It involves using a graft made from the amniotic membrane, which is the innermost layer of the placenta. This membrane has natural healing properties and is used to cover the area where the pterygium was removed, helping to protect the eye and reduce the chance of recurrence.

Pterygium – Pterygium is a non-cancerous growth of the conjunctiva, the clear tissue covering the white part of the eye and the inside of the eyelids. It often appears as a wedge-shaped growth that can extend onto the cornea, the clear front part of the eye. The condition is commonly associated with exposure to sunlight and wind, and it may cause irritation, redness, or a feeling of having something in the eye. Over time, the growth can become larger and may interfere with vision if it extends over the cornea. Pterygium is more common in people who spend a lot of time outdoors, especially in sunny climates. The progression of the disease can vary, with some cases remaining stable while others may grow and require surgical intervention.

Trial ID:

2025-520640-15-00

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study on Fibrin Matrix and Autologous Growth Factor Eye Drops for Pterygium Surgery Patients

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?