E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Subconjunctival haemorrhages after surgery of vitrectomía with 23G |
Hemorragias subconjuntivales tras cirugía de vitrectomía con 23G |
|
E.1.1.1 | Medical condition in easily understood language |
Subconjunctival haemorrhages after surgery of vitrectomía with 23G |
Hemorragias subconjuntivales tras cirugía de vitrectomía con 23G |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Eye Diseases [C11] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 15.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10042341 |
E.1.2 | Term | Subconjunctival haemorrhage |
E.1.2 | System Organ Class | 10015919 - Eye disorders |
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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 determine if it can be prevented and in that percentage the appearance of subconjunctival haemorrhages after surgery of vitrectomía with 23G, by means of the use of brimonidina in collyrium in the preoperative medication. |
Determinar si puede prevenirse y en que porcentaje la aparición de hemorragias subconjuntivales tras cirugía de vitrectomía con 23G, mediante el uso de brimonidina en colirio en la medicación preoperatoria. |
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E.2.2 | Secondary objectives of the trial |
To determine if there are individual preconditions that alter the response |
Determinar si existen condiciones previas individuales que alteren la respuesta. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Women and men over 18 years 2. Patients who are going to be operated on 23G vitrectomy 3. To sign the informed consent. |
1. Mujeres y hombres mayores de 18 años. 2. Pacientes que vayan a ser intervenidos de vitrectomía 23G. 3. Firmar el consentimiento informado. |
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E.4 | Principal exclusion criteria |
1. Other associated surgeries that incluye conjunctival incision 2. Known allergy to study drug 3. Subconjunctival haemorrhage in the eye of the study before the start of premedication, from any source (trauma, previous surgery) |
1. Otras cirugías asociadas que incluyan incisión conjuntival 2. Alergia conocida al fármaco del estudio 3. Hemorragia subconjuntival en el ojo de estudio presente antes del comienzo de la premedicación, de cualquier origen (trauma, cirugía previa) |
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E.5 End points |
E.5.1 | Primary end point(s) |
Number of quadrants affected by subconjunctival haemorrhage at each follow-up visit. |
Número de cuadrantes afectos de hemorragia subconjuntival en cada una de las visitas de seguimiento |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
If the patient is hypertensive or diabetic or is taking antiplatelet agents or anticoagulants. |
Si el paciente es hipertenso o diabético o toma antiagregantes o anticoagulantes. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
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 | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
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 |
|
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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |