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.
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Kontakter och platser
Studiekontakt
- Namn: Yağmur M Okumuş, Assistant Professor, DDS, Phd
- Telefonnummer: +90 5304054615
- E-post: yagmur.malkoc@medipol.edu.tr
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
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.'
Beskrivning
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.
Studieplan
Hur är studien utformad?
Designdetaljer
- Observationsmodeller: COHORT
- Tidsperspektiv: OTHER
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
|---|---|
|
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. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in Peripapillary Retinal Nerve Fiber Layer (RNFL) Thickness
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in Optic Disc Area and Elongation Ratio
Tidsram: 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
|
Samarbetspartners och utredare
Sponsor
Utredare
- Studierektor: Sina Uçkan, prof., Medipol University
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- IstanbulMUH-DF-YM-03
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