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Predictive OCTA Biomarkers After Endoscopic Endonasal Pituitary Surgery

Optical Cohrence Tomography Angiography as a New Predictive Biomarker in Anatomical and Functional Recovery After Endoscopic Endonasal Pituitary Surgery: a Prospective Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04840771
Enrollment
8
Registered
2021-04-12
Start date
2020-06-01
Completion date
2020-07-31
Last updated
2021-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pituitary Adenoma

Brief summary

This study evaluates the structural parameters, by spectral domain optical coherence tomography (OCT), retinal vessel density, using OCT angiography, and visual acuity in patients that received endoscopic endonasal approach for the removal of an intra-suprasellar pituitary adenoma compressing the optic nerve.

Detailed description

The primary outcome was to detect the changes in visual acuity, retinal structural and vascular features at 48 hours and 1 year after Endoscopic Endonasal Approach for the removal of an intra-suprasellar pituitary adenoma compressing the optic nerve. The secondary outcome was to identify potential biomarker that could predict the functional recovery at 1 year follow up.

Interventions

Surgical treatment consisted of an endoscopic endonasal approach using a rigid 0-degree endoscope, 18 cm in length and 4 mm in diameter.

Sponsors

Federico II University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
40 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* age older than 40 years * diagnosis of pituitary adenoma * treatment-naïve with Endoscopic Endonasal Pituitary Surgery * absence of other neurological diseases * absence of vitreoretinal and vascular retinal diseases

Exclusion criteria

* age younger than 40 years * No diagnosis of pituitary adenoma * previous treatments with Endoscopic Endonasal Pituitary Surgery * presence of neurological diseases * presence of vitreoretinal and vascular retinal diseases

Design outcomes

Primary

MeasureTime frameDescription
Comparison between retinal structures before and 48 hours and 1 year after Endoscopic Endonasal Pituitary Surgery48 hours and 1 year follow up8 patients with pituitary adenoma compressing optic chiasm. Changes in thickness of ganglion cell complex (microns) and in thickness of retinal nerve fiber layer (microns) before and 48 hours and 1 year after Endoscopic Endonasal Pituitary Surgery
Comparison between retinal microvasculature before and 48 hours and 1 year after Endoscopic Endonasal Pituitary Surgery48 hours and 1 year follow up8 patients with pituitary adenoma compressing optic chiasm. Changes in retinal vessel density (percent) in macular and papillary regions before and 48 hours and 1 year after Endoscopic Endonasal Pituitary Surgery

Secondary

MeasureTime frameDescription
Correlation between retinal structures and visual acuity after Endoscopic Endonasal Pituitary Surgery1 year follow up8 patients with pituitary adenoma compressing optic chiasm underwent Endoscopic Endonasal Pituitary Surgery. Correlation between ganglion cell complex, retinal nerve fiber layer thicknesses (microns) at baseline and visual acuity recovery (logMAR) 1 year after surgery.
Correlation between retinal microvasculature and visual acuity after Endoscopic Endonasal Pituitary Surgery1 year follow up8 patients with pituitary adenoma compressing optic chiasm underwent Endoscopic Endonasal Pituitary Surgery. Correlation between retinal vessel density (percent) at baseline and visual acuity recovery (logMAR) 1 year after surgery.

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026