- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00190190
Internal Limiting Membrane Peeling for Large Macular Holes
Comparison of the Success Rate of a Procedure With Peeling of Limiting the Intern of the Retina Versus a Traditional Procedure Without Peeling of Limiting, at Patients Presenting a Macular Hole.
Rational of the study: for macular holes larger than 400 µm the rate of failure is of more than 20%. It is for these eyes that it is necessary to show the benefit of internal limiting membrane (ILM) peeling in term of vision and success rate. In order to test the benefit of this gesture, it is necessary to make a randomized study.
Primary objective: To show that the percentage of success (anatomical closing, confirmed by OCT) at third postoperative month is higher in the ILM peeling group.
Design of the study: Randomized multicentric study, in parallel groups, with individual benefit for the patient.
Tested Hypothesis: The success rate of the surgery of idiopathic macular holes larger than 400 µm is increased by the peeling of the MLI.
Awaited results: To show that the success rate of the surgery of idiopathic macular holes larger than 400 µm is improved by ILM peeling. This category could then have a success rate similar to the small holes. If this difference is not proven, it will remain no justification to continue this procedure which represents little risk but which is not either without consequence.
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
Rational of the study: for macular holes larger than 400 µm the rate of failure is of more than 20%. It is for these eyes that it is necessary to show the benefit of internal limiting membrane (ILM) peeling in term of vision and success rate. In order to test the benefit of this gesture, it is necessary to make a randomized study.
Primary objective: To show that the percentage of success (anatomical closing, confirmed by OCT) at three postoperative months is higher in the ILM peeling group.
Design of the study: Randomized multicentric study, in parallel groups, with individual benefit for the patient.
Tested Hypothesis: The success rate of the surgery of idiopathic macular holes larger than 400 µm is increased by the peeling of the MLI.
Secondary objectives: - Percentage of success according to the effective success of peeling (failure, partial peeling, peeling 360°) in the peeling group of the MLI. - Gain of ETDRS visual acuity in the third postoperative month.- Progression of cataract - Frequency of the complications.
Number of subjects and duration of the study: 80 patients older than 18 yo , presenting a macular hole > 400 µm, divided into two parallel groups will be included and followed up 3 months. The estimated total duration of the study is 27 months.
Statistical analysis: The percentages of success in the 2 groups will be compared by a Chi ² or Fisher exact test. The test Q of COCHRAN will be used to take into account the ordered character of the categories.
Intermediate Analysis: An intermediate analysis is envisaged. The procedure of adjustment of the risk of Lan and DeMets will be used.
Awaited results: To show that the success rate of the surgery of idiopathic macular holes larger than 400 µm is improved by ILM peeling. This category could then have a success rate similar to the small holes. If this difference is not proven, it will remain no justification to continue this procedure which represents little risk but which is not either without consequence.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Paris, Francia, 75010
- Service d'Ophtalmolgie de l'Hôpital Lariboisière
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Age equal to or higher than 18 years
- Patient presenting a TM idiopathic of stage 2, 3 or 4
- Macular hole > 400 µm in diameter
- Patient having been informed of the objectives and constraints of the study and having signed an informed consent
Exclusion Criteria:
- Patient age < 18 years.
- Patient having a strong myopia of the operated eye: correction carried or optimal >6 dioptres
- Patient MONOPHTHALMIA.
- Patient pseudophakia presenting an "insufficient" plan capsular CRYTALLINE.
- Patient presenting a cataract making impossible a good visualization of the bottom of eye.
- Patient presenting an important opacification capsular.
- Patient presenting an associated ocular pathology being able to interfere with the operation.
- Patient presenting a TM already operated of the eye to include
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Sperimentale: 1
With Peeling of Limiting the Intern of the Retina
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With Peeling of Limiting the Intern of the Retina
|
Comparatore attivo: 2
Traditional Procedure Without Peeling of Limiting
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Traditional Procedure Without Peeling of Limiting
Altri nomi:
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
---|---|
percentage of success (anatomical closing, confirmed by OCT) at third postoperative month, in both groups
Lasso di tempo: at 3 months
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at 3 months
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Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
---|---|
Percentage of success according to the effective success of peeling (failure, partial peeling, peeling 360°) in the peeling group of the MLI.
Lasso di tempo: at 3 months
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at 3 months
|
Gain of ETDRS visual acuity in the third postoperative month
Lasso di tempo: at 3 months
|
at 3 months
|
Progression of cataract
Lasso di tempo: at 3 months
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at 3 months
|
Frequency of the complications.
Lasso di tempo: at 3 months
|
at 3 months
|
Collaboratori e investigatori
Investigatori
- Investigatore principale: Ramin TADAYONI, MD, Assistance Publique - Hôpitaux de Paris
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- P040604
- PS040604
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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