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.
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Anslået)
Kontakter og lokationer
Studiekontakt
- Navn: Yağmur M Okumuş, Assistant Professor, DDS, Phd
- Telefonnummer: +90 5304054615
- E-mail: yagmur.malkoc@medipol.edu.tr
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
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.'
Beskrivelse
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
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: COHORT
- Tidsperspektiver: OTHER
Kohorter og interventioner
Gruppe / kohorte |
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. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Peripapillary Retinal Nerve Fiber Layer (RNFL) Thickness
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Optic Disc Area and Elongation Ratio
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studieleder: Sina Uçkan, prof., Medipol University
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- IstanbulMUH-DF-YM-03
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .