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.
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Stimato)
Contatti e Sedi
Contatto studio
- Nome: Yağmur M Okumuş, Assistant Professor, DDS, Phd
- Numero di telefono: +90 5304054615
- Email: yagmur.malkoc@medipol.edu.tr
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
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.'
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Modelli osservazionali: COHORT
- Prospettive temporali: OTHER
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
|---|---|
|
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. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change in Peripapillary Retinal Nerve Fiber Layer (RNFL) Thickness
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change in Optic Disc Area and Elongation Ratio
Lasso di tempo: 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
|
Collaboratori e investigatori
Sponsor
Investigatori
- Direttore dello studio: Sina Uçkan, prof., Medipol University
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Termini relativi a questo studio
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Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- IstanbulMUH-DF-YM-03
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