Study to evaluate the efficacy of fibrin membrane graft with eye drops concentrated in autologous growth factors in primary pterygium surgery comparing it with amniotic membrane graft

Randomized clinical trial to evaluate the efficacy of fibrin membrane graft with eye drops concentrated in autologous growth factors in primary pterygium surgery comparing it with amniotic membrane graft in terms of recurrence during the first year after surgery

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-003042-16-ES

Enrollment

110

Registered

2018-10-09

Start date

2019-02-08

Completion date

Unknown

Last updated

2019-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pterigyum

Interventions

Product Name: PRP Pharmaceutical Form: Eye drops INN or Proposed INN: Platelet Rich Plasma (PRP) Other descriptive name: AUTOLOGOUS PLASMA

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Uni or bilateral primary pterygium with growth of fibrovascular proliferation. - Patients between 20 and 60 years old - Corneal invasion with risk of visual affectation and / or eye discomfort due to pterygium. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 110 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Prior pterygium surgery (recurrent pterygium) - Pseudopterigio - Use of topical or systemic immunosuppressive or immunomodulatory treatment - Use of chronic topical ocular treatment except artificial tears - Antecedents of palpebral disease or ocular surface

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the efficacy, through the rate of recurrence during the first postoperative year, of the fibrin membrane graft and concentrated eye drops in autologous growth factors in primary pterygium surgery, comparing it with the amniotic membrane graft.;Timepoint(s) of evaluation of this end point: It will be evaluated at month, two months, three months, six months and the year after the intervention.; Secondary Objective: - Evaluate and compare the epithelization time after surgery in both techniques - Evaluate tissue healing in both techniques. - Evaluate the safety and surgical and post-surgical complications of both techniques: scleritis, persistent epithelial defect, graft retraction, graft loss, intraocular hypertension secondary to corticosteroids. ;Primary end point(s): Recurrence rate. Defined as the number of recurrences per technique divided between surgeries performed with an amniotic membrane implant and those using a fibrin graft rich in growth factors. Understanding as recurrence the appearance of fibrovascular proliferation invading the corneal limbus and the cornea.	—

Measure

Time frame

Main Objective: To evaluate the efficacy, through the rate of recurrence during the first postoperative year, of the fibrin membrane graft and concentrated eye drops in autologous growth factors in primary pterygium surgery, comparing it with the amniotic membrane graft.;Timepoint(s) of evaluation of this end point: It will be evaluated at month, two months, three months, six months and the year after the intervention.; Secondary Objective: - Evaluate and compare the epithelization time after surgery in both techniques - Evaluate tissue healing in both techniques. - Evaluate the safety and surgical and post-surgical complications of both techniques: scleritis, persistent epithelial defect, graft retraction, graft loss, intraocular hypertension secondary to corticosteroids. ;Primary end point(s): Recurrence rate. Defined as the number of recurrences per technique divided between surgeries performed with an amniotic membrane implant and those using a fibrin graft rich in growth factors. Understanding as recurrence the appearance of fibrovascular proliferation invading the corneal limbus and the cornea.

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Secondary

Measure	Time frame
Secondary end point(s): - Epithelization time in both techniques. Defined as the number of days it takes to grow the epithelial cells on the amniotic membrane or fibrin graft by measuring it with fluorescein staining (epithelialization corresponds to negative staining). While there is an epithelial defect, the patient will be visited every 2 days. - Correct tissue healing (YES / NO). Defined as the epithelization and healing of the conjunctiva with appearance similar to the healthy conjunctiva, without granulomas, without lines of fibrosis, without vascular proliferation. - Security. Defined as the number of surgical complications in both techniques during the first three months of follow-up. The following are mainly registered: scleritis, persistent epithelial defect, graft retraction, graft loss, granuloma, intraocular hypertension secondary to corticosteroids. ;Timepoint(s) of evaluation of this end point: It will be evaluated at month, two months, three months, six months and the year after the intervention.	—

Measure

Time frame

Secondary end point(s): - Epithelization time in both techniques. Defined as the number of days it takes to grow the epithelial cells on the amniotic membrane or fibrin graft by measuring it with fluorescein staining (epithelialization corresponds to negative staining). While there is an epithelial defect, the patient will be visited every 2 days. - Correct tissue healing (YES / NO). Defined as the epithelization and healing of the conjunctiva with appearance similar to the healthy conjunctiva, without granulomas, without lines of fibrosis, without vascular proliferation. - Security. Defined as the number of surgical complications in both techniques during the first three months of follow-up. The following are mainly registered: scleritis, persistent epithelial defect, graft retraction, graft loss, granuloma, intraocular hypertension secondary to corticosteroids. ;Timepoint(s) of evaluation of this end point: It will be evaluated at month, two months, three months, six months and the year after the intervention.

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Countries

Spain

Contacts

Public ContactUICEC Sant Pau

Institut de Recerca H. Santa Creu i Sant Pau

epenag@santpau.cat+34935537635

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026