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

Phase 1

• Conditions: Pterigyum; Therapeutic area: Body processes [G] - Ocular Physiological Phenomena [G14]

• Registration Number: EUCTR2018-003042-16-ES
• Lead Sponsor: Institut de Recerca H. de la Santa Creu i Sant Pau

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-10-09
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 110

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

- 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified