Outcomes of Macular Hole Surgery With Inverted Flap With vs Without Post op Posturing With SF6 in Macular Hole More Than 400 Micrometres
This study evaluated the outcomes of surgery for large full-thickness macular holes measuring more than 400 micrometres using the inverted internal limiting membrane flap technique with sulphur hexafluoride (SF6) gas tamponade. The study was conducted at the Department of Ophthalmology, Lahore General Hospital, Lahore. A total of 52 male and female patients aged 52-84 years with full-thickness macular holes were included.
All patients underwent 23-gauge pars plana vitrectomy with hyaloidectomy and inverted internal limiting membrane flap surgery after staining with 0.05% Brilliant Blue. Patients were divided into two groups according to postoperative positioning. One group performed postoperative face-down posturing, whereas the other group did not perform face-down posturing. The study examined whether successful closure of large macular holes could be achieved without postoperative face-down positioning after surgery with SF6 gas tamponade.
Patients were followed on postoperative days 1, 7, 30, and 90. The main outcome was anatomical closure of the macular hole, which was assessed using optical coherence tomography (OCT). Successful treatment was defined as complete anatomical closure of the macular hole. The outcomes of patients who performed face-down posturing were compared with those who did not perform postoperative posturing to determine whether face-down positioning was necessary following surgery for macular holes larger than 400 micrometres.
Aperçu de l'étude
Statut
Les conditions
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
Punjab Province
-
Lahore, Punjab Province, Pakistan, 54000
- Lahore General Hospital, Lahore
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
Inclusion Criteria:
- Gender: male and female
- All patient having age between 52-84 years
- All the patients with full thickness macular hole
- All the patients with written informed consent
Exclusion Criteria:
- Patients with high myopia.
- Patient having age related macular degenerations (AMD).
- Patient having any chorioretinal disease or Diabetic retinopathy.
Secondary MH causes
- Trauma.
- Uveitis.
- Cystic macular edema.
- Age-related macular degeneration
- Glaucoma or ocular hypertension
- corneal opacity
- Patient with history of previously intraocular or vitrectomy surgery other than uncomplicated cataract surgery.
- Patient with history of previous laser photocoagulation.
- Presence of traction on the macula (OCT).
- Patient with significant media opacity preventing retinal view or poor image quality.
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 |
|---|---|
|
Expérimental: Face-Down Posturing Group
Patients underwent 23-gauge pars plana vitrectomy with hyaloidectomy and inverted internal limiting membrane flap surgery after staining with 0.05% Brilliant Blue, followed by SF6 gas tamponade.
After surgery, patients performed postoperative face-down posturing.
|
Patients underwent 23-gauge pars plana vitrectomy with hyaloidectomy and inverted internal limiting membrane flap surgery with SF6 gas tamponade.
Patients performed face-down posturing after surgery according to the postoperative instructions.
|
|
Comparateur actif: No Face-Down Posturing Group
Patients underwent the same 23-gauge pars plana vitrectomy with hyaloidectomy and inverted internal limiting membrane flap surgery after staining with 0.05% Brilliant Blue, followed by SF6 gas tamponade.
Patients did not perform postoperative face-down posturing.
|
Patients underwent 23-gauge pars plana vitrectomy with hyaloidectomy and inverted internal limiting membrane flap surgery with SF6 gas tamponade.
Patients were managed without postoperative face-down posturing.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Anatomical Closure of the Macular Hole on OCT
Délai: 3 months after surgery.
|
Proportion of participants with complete anatomical closure of the macular hole on optical coherence tomography.
|
3 months after surgery.
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Ahmad Fauzan, Lahore General Hospital, Lahore
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
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
Autres numéros d'identification d'étude
- LahoreGeneralH19
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .