E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Body processes [G] - Ocular Physiological Phenomena [G14] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
Evaluar la eficacia, a través de la tasa de recidiva durante el primer año postoperatorio, del injerto de membrana de fibrina y colirio de concentrado en factores de crecimiento autólogos en la cirugía de pterigio primario, comparándola con el injerto de membrana amniótica. |
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E.2.2 | Secondary objectives of the trial |
- 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. |
- Evaluar y comparar el tiempo de epitelización tras la cirugía en ambas técnicas - Evaluar la cicatrización tisular en ambas técnicas. - Evaluar la seguridad y las complicaciones quirúrgicas y post quirúrgicas de ambas técnicas: escleritis, defecto epitelial persistente, retracción del injerto, pérdida del injerto, hipertensión intraocular secundaria a los corticoesteroides. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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. |
- Pterigio primario uni o bilateral con crecimiento de la proliferación fibrovascular. - Pacientes con edad entre 20 y 60 años - Invasión corneal con riesgo de afectación visual y/o molestias oculares debidas al pterigio. |
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E.4 | Principal 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 |
- Cirugía previa de pterigio (pterigio recidivante) - Pseudopterigio - Uso de tratamiento inmunosupresor o inmunomodulador tópico o sistémico - Uso de tratamiento ocular tópico crónico excepto las lágrimas artificiales - Antecedentes de enfermedad palpebral o de la superficie ocular |
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E.5 End points |
E.5.1 | 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. |
Tasa de recidivas. Definida como el número de recidivas por técnica dividida entre las cirugías realizadas con implante de membrana amniótica y las que se usa el injerto de fibrina rica en factores de crecimiento. Entendiendo como recidiva la aparición de proliferación fibrovascular invadiendo el limbo corneal y la córnea. |
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E.5.1.1 | 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. |
Se evaluará al mes, dos meses, tres meses, seis meses y al año tras la intervención. |
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E.5.2 | 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. |
- Tiempo de epitelización en ambas técnicas. Definido como el número de días que tarda en crecer las células epiteliales sobre el injerto de membrana amniótica o de fibrina midiéndolo con la tinción de fluoresceína (epitelización corresponde a tinción negativa). Mientras exista defecto epitelial el paciente se visitará cada 2 días. - Cicatrización tisular correcta (SI/NO). Definida como la epitelización y cicatrización de la conjuntiva con aspecto similar a la conjuntiva sana, sin granulomas, sin líneas de fibrosis, sin proliferación vascular. - Seguridad. Definida como el número de complicaciones quirúrgicas en ambas técnicas durante los primeros tres meses de seguimiento. Se registrarán principalmente las siguientes: escleritis, defecto epitelial persistente, retracción del injerto, pérdida del injerto, granuloma, hipertensión intraocular secundaria a los corticoesteroides. |
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E.5.2.1 | 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. |
Se evaluará al mes, dos meses, tres meses, seis meses y al año tras la intervención. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Membrana amniótica |
Amniotic membrane |
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E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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LVLS |
Última visita del último sujeto |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |