- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT05331664
Étude sur la vitrectomie pars plana sans goutte (DVS)
To demonstrate that intraoperative use of subtenon triamcinolone acetonide at the time of surgery without postoperative eye drops is non-inferior to the regimen of postoperative eye drops following primary pars plana vitrectomy for retinal detachment.
Aperçu de l'étude
Statut
Les conditions
Description détaillée
This is a non-inferiority, single-center, randomized, controlled, open-label clinical trial. Investigators will recruit patients that present to their clinic or emergency department with newly diagnosed mac-on or mac-off rhegmatogenous retinal detachment. Patients will be randomized to one of the following groups:
- Group 1: A total of 84 study subjects (84 eyes) will receive topical antibiotic qid for one week after surgery, topical prednisolone 1% qid tapered by one drop weekly for four weeks (4/3/2/1 taper), and topical atropine 1% daily for one week.
- Group 2: A total of 84 study subjects (84 eyes) will receive sub-tenon injection of triamcinolone acetonide (40 mg/mL) at the time of surgery, with no post-operative eye drops.
Both groups will receive subconjunctival injection of antibiotic (cefazolin 50 mg/0.5 ml, moxifloxacin 0.5 mg/0.1 ml, or vancomycin 1 mg/0.1 ml) and subconjunctival injection of dexamethasone (4 mg/ml) at the time of surgery, as well as atropine 1% and antibiotic-steroid ointment (neomycin-polymyxin B-dexamethasone) at the time of surgery.
Type d'étude
Inscription (Réel)
Phase
- Phase 4
Contacts et emplacements
Lieux d'étude
-
-
Massachusetts
-
Boston, Massachusetts, États-Unis, 02114
- Massachusetts Eye and Ear
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Primary rhegmatogenous retinal detachment (mac-on or mac-off) requiring pars plana vitrectomy (23, 25 and 27-gauge)
Exclusion Criteria:
- Need for concomitant lensectomy or cataract surgery
- Pars plana vitrectomy taking place more than seven days after the initial diagnosis
- History of any prior vitreoretinal surgery (excluding laser surgery) in surgical eye
- History of previous retinal detachment in surgical eye
- History of ocular incisional surgery within six months of surgery (excluding laser surgery) in surgical eye
- History of ocular laser surgery within 1 month in surgical eye
- History of intravitreal injection within 1 month in surgical eye
- Diagnosis of glaucoma or intraocular pressure more than 21 mmHg in either eye
- Active or chronic or recurrent uncontrolled ocular or systemic disease
- Active or history of chronic or recurrent inflammatory eye disease
- Previous history of steroid response
- Current treatment with oral, topical, or intravitreal corticosteroids
- Presence of proliferative vitreoretinopathy at the time of diagnosis
- Presence of giant retinal tear at the time of diagnosis
- Diagnosis of proliferative diabetic retinopathy
- Anterior chamber inflammation on presentation in either eye
- Signs of ocular infection at presentation in either eye
- Acute external ocular infections
- Known or suspected sensitivity or allergy to any of the medications used in the operation or postoperatively
- Inability to use or apply topical eye drops
- Requirement for silicone oil as a tamponade agent
- Individuals with impaired decision-making capacity
- Non-English-speaking subjects
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur actif: Group 1
|
Standard of care surgery Antibiotic eye drop 4 times per day for 1 week after surgery
Autres noms:
Steroid eye drop 4 times per day tapered by one drop weekly for 4 weeks (4/3/2/1 taper) after surgery
Autres noms:
Eye drop daily for 1 week after surgery
Autres noms:
|
|
Comparateur actif: Group 2
|
Standard of care surgery Sub-tenon injection of triamcinolone acetonide (40mg/mL) at the time of surgery
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Mean anterior chamber cell
Délai: Day 7 after surgical procedure
|
Mean anterior chamber cell based on SUN (Standardization of Uveitis Nomenclature) criteria as measured by Slit Lamp Biomicroscopy |
Day 7 after surgical procedure
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Mean anterior chamber cell
Délai: Day 1, 30 and 90 after surgical procedure
|
Mean anterior chamber cell based on Standardization of Uveitis Nomenclature (SUN) criteria as measured by Slit Lamp Biomicroscopy |
Day 1, 30 and 90 after surgical procedure
|
|
Need for rescue medication (corticosteroid)
Délai: Day 1, 7, 30 and 90 after surgical procedure
|
Need for additional medication (corticosteroid) to control post-operative inflammation |
Day 1, 7, 30 and 90 after surgical procedure
|
|
Intraocular pressure less than 5 or more 30 mmHg
Délai: Day 1, 7, 30 and 90 after surgical procedure
|
Intraocular pressure measured by applanation tonometer or tono-pen |
Day 1, 7, 30 and 90 after surgical procedure
|
|
Need for medications to reduce intraocular pressure
Délai: Day 1, 7, 30 and 90 after surgical procedure
|
Need for additional medication to reduce intraocular pressure |
Day 1, 7, 30 and 90 after surgical procedure
|
|
Visual acuity
Délai: Day 1, 7, 30 and 90 after surgical procedure
|
Best-corrected visual acuity measured using Snellen chart |
Day 1, 7, 30 and 90 after surgical procedure
|
|
Degree of pain
Délai: Day 1, 7, 30 and 90 after surgical procedure
|
Degree of pain on a pain scale of 1-10 (0: pain free, 10: unspeakable pain) |
Day 1, 7, 30 and 90 after surgical procedure
|
|
Self-reported adherence to positioning
Délai: Day 1 and 7 after surgical procedure
|
Assessment of self-reported adherence to positioning: "Over the past day or week, what percentage of time or number of hours per day do you think you adhered with the recommended positioning?" |
Day 1 and 7 after surgical procedure
|
|
Self-reported adherence to eye drops
Délai: Day 1, 7 and 30 after surgical procedure
|
Assessment of self-reported adherence to eye drops in the control group: "Over the past week or month, what percentage of your drops do you think you took correctly?" |
Day 1, 7 and 30 after surgical procedure
|
|
Progression of cataract
Délai: Day 30 and 90 after surgical procedure
|
Evaluation of progression of cataract by Slit Lamp Biomicroscopy |
Day 30 and 90 after surgical procedure
|
|
Adverse events
Délai: Day 1, 7, 30 and 90 after surgical procedure
|
Adverse Events including: Endophthalmitis, Re-detachment requiring surgery, Intraocular pressure requiring medication, Need for additional procedures, Any other adverse events |
Day 1, 7, 30 and 90 after surgical procedure
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Nimesh A. Patel, MD, Massachusetts Eye and Ear
Publications et liens utiles
Publications générales
- Paccola L, Jorge R, Barbosa JC, Costa RA, Scott IU. Anti-inflammatory efficacy of a single posterior subtenon injection of triamcinolone acetonide versus prednisolone acetate 1% eyedrops after pars plana vitrectomy. Acta Ophthalmol Scand. 2007 Sep;85(6):603-8. doi: 10.1111/j.1600-0420.2007.00923.x. Epub 2007 Apr 24.
- Brown GT, Karth PA, Hunter AA. Novel Postoperative Dropless Protocol for Micro-Incision Vitrectomy Surgery. Ophthalmic Surg Lasers Imaging Retina. 2021 Nov;52(11):587-591. doi: 10.3928/23258160-20211014-01. Epub 2021 Nov 1.
- Bonfiglio V, Reibaldi M, Macchi I, Fallico M, Pizzo C, Patane C, Russo A, Longo A, Pizzo A, Cillino G, Cillino S, Vadala M, Rinaldi M, Rejdak R, Nowomiejska K, Toro MD, Avitabile T, Ortisi E. Preoperative, Intraoperative and Postoperative Corticosteroid Use as an Adjunctive Treatment for Rhegmatogenous Retinal Detachment. J Clin Med. 2020 May 21;9(5):1556. doi: 10.3390/jcm9051556.
- Assil KK, Greenwood MD, Gibson A, Vantipalli S, Metzinger JL, Goldstein MH. Dropless cataract surgery: modernizing perioperative medical therapy to improve outcomes and patient satisfaction. Curr Opin Ophthalmol. 2021 Jan;32 Suppl 1:S1-S12. doi: 10.1097/ICU.0000000000000708.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Processus pathologiques
- Conditions pathologiques, signes et symptômes
- Inflammation
- Peptides
- Acides aminés, peptides et protéines
- Protéines
- Produits chimiques organiques
- Composés hétérocycliques
- Composés hétérocycliques, 2 anneaux
- Composés hétérocycliques, anneau fusionné
- Lipides
- Alcaloïdes
- Composés polycycliques
- Prégnades
- Grossesse
- Stéroïdes
- Composés à anneau fusionné
- Stéroïdes, fluorés
- Protéines membranaires
- Composés Aza
- Composés macrocycliques
- Fluoroquinolones
- 4-quinolones
- Quinolones
- Quinolines
- Peptides, cyclique
- Lipopeptides
- Composés hétérocycliques, anneau ponté
- Dérivés de l'atropine
- Tropanes
- Composés azabicyclo
- Alcaloïdes belladonna
- Alcaloïdes solanacés
- Composés bicyclo pontés, hétérocyclique
- Peptides cationiques antimicrobiens
- Peptides antimicrobiens
- Protéines Cytotoxiques Formant des Pores
- Moxifloxacine
- Atropine
- Triamcinolone
- Acétonide de triamcinolone
- Polymyxines
- acétate de prednisolone
- 1(beta)-D-arabinofuranosylcytosine-5'-diphosphate prednisolone
Autres numéros d'identification d'étude
- 2022P000046
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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