Subclinical Optic Nerve Changes After Le Fort I Osteotomy
Evaluation of Subclinical Optic Nerve Head Changes After Le Fort I Osteotomy Using Retinal Nerve Fiber Layer Optical Coherence Tomography
Le Fort I osteotomy is a common jaw surgery that includes a step called pterygomaxillary dysjunction, during which force applied with a surgical instrument (osteotome) can be transmitted toward the eye socket (orbit) and the optic nerve canal. Serious eye complications after this surgery are rare, but it is not known whether smaller, subclinical changes occur in the optic nerve that go unnoticed without special testing. This study uses a non-invasive eye imaging test called optical coherence tomography (OCT) to measure the thickness of the nerve fiber layer around the optic nerve, before and after Le Fort I surgery, to find out whether such changes occur.
Aperçu de l'étude
Statut
Les conditions
Description détaillée
Fifty patients aged 18-45 years scheduled for isolated Le Fort I osteotomy or Le Fort I osteotomy combined with bilateral sagittal split osteotomy (BSSO) will be enrolled in this single-center, prospective, observational cohort study. Each patient serves as their own control (within-subject comparison across time points). All participants will undergo ophthalmologic examination, RNFL-OCT imaging, optic disc morphology assessment (disc area, elongation ratio, presence of disc head hemorrhage), and Humphrey 30-2 visual field testing at three time points: preoperatively (T0, within 1 week before surgery), 1 week postoperatively (T1), and 3 months postoperatively (T2). All ophthalmologic measurements will be performed by a single examiner blinded to intraoperative surgical details, using the same device throughout. Maxillary advancement amount and pterygomaxillary junction depth/concavity angle will be measured preoperatively on CBCT (pterygomaxillary junction measured bilaterally, with Observer 1 measuring twice for intraobserver reliability and Observer 2 measuring once for interobserver reliability). No intervention, randomization, or treatment-group allocation occurs as part of this study; all participants receive their routine, already-planned orthognathic surgical care. A priori power analysis (G*Power, RM ANOVA within-between interaction, f=0.25, epsilon=1, alpha=0.05, power=0.90) indicated a minimum required sample size of N=36; n=50 was set to allow for attrition.
Type d'étude
Inscription (Estimé)
Contacts et emplacements
Coordonnées de l'étude
- Nom: Yağmur M Okumuş, Assistant Professor, DDS, Phd
- Numéro de téléphone: +90 5304054615
- E-mail: yagmur.malkoc@medipol.edu.tr
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
Adult patients aged 18-45 years scheduled for isolated Le Fort I osteotomy or Le Fort I combined with bilateral sagittal split osteotomy (BSSO) at Istanbul Medipol University, with no pre-existing ocular or orbital pathology that could independently affect retinal nerve fiber layer thickness or optic disc morphology.'
La description
Inclusion Criteria:
Aged 18-45 years, able to provide written informed consent. Isolated Le Fort I osteotomy or Le Fort I + BSSO (bilateral sagittal split osteotomy) planned.
ASA Physical Status Classification I-II. Standard osteotome technique used for pterygomaxillary dysjunction. Sufficient ocular media clarity to permit OCT imaging.
Exclusion Criteria:
Known glaucoma, optic neuropathy, retinal disease, or other ocular pathology affecting the retinal nerve fiber layer.
Prior ocular/orbital surgery or trauma. Craniofacial syndrome (e.g., cleft lip/palate). Segmental Le Fort osteotomy or revision orthognathic surgery. Unwilling or unable to provide informed consent.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: COHORT
- Perspectives temporelles: OTHER
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
|
Le Fort I osteotomy cohort
Patients undergoing isolated Le Fort I osteotomy or Le Fort I combined with bilateral sagittal split osteotomy (BSSO). No randomization or treatment allocation; all participants receive their routine, already-planned orthognathic surgical care. Diagnostic Test: RNFL-OCT and optic disc morphology assessment (disc area, elongation ratio, disc head hemorrhage), performed preoperatively (T0) and at 1 week (T1) and 3 months (T2) postoperatively. Diagnostic Test: Humphrey 30-2 visual field testing, performed at the same three time points. Diagnostic Test: Preoperative CBCT measurement of pterygomaxillary junction depth and concavity angle, and maxillary advancement amount from surgical planning data. |
Peripapillary retinal nerve fiber layer thickness and optic disc morphology (disc area, elongation ratio, presence of disc head hemorrhage) measured by optical coherence tomography, performed preoperatively (T0) and at 1 week (T1) and 3 months (T2) postoperatively. Humphrey 30-2 Visual Field Testing Açıklama: Standard automated perimetry (Humphrey 30-2 program) performed at the same three time points (T0, T1, T2) to assess mean deviation and pattern standard deviation. Cone-beam computed tomography measurement of pterygomaxillary junction depth and concavity angle, and maxillary advancement amount from virtual surgical planning data, obtained preoperatively. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in Peripapillary Retinal Nerve Fiber Layer (RNFL) Thickness
Délai: Baseline (T0, preoperative) to 3 months (T2) postoperatively
|
Change in peripapillary retinal nerve fiber layer (RNFL) thickness, measured by optical coherence tomography (OCT), from baseline (T0, preoperative) to 1 week (T1) and 3 months (T2) after Le Fort I osteotomy. |
Baseline (T0, preoperative) to 3 months (T2) postoperatively
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in Optic Disc Area and Elongation Ratio
Délai: Baseline (T0) to 3 months (T2) postoperatively
|
Change in optic disc area and elongation ratio (vertical/horizontal), measured by OCT, from baseline (T0) to 1 week (T1) and 3 months (T2) after Le Fort I osteotomy. |
Baseline (T0) to 3 months (T2) postoperatively
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Directeur d'études: Sina Uçkan, prof., Medipol University
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
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
- IstanbulMUH-DF-YM-03
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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