Citicoline in Non-Arteritic Ischemic Optic Neuropathy
NCT03758118
Non-arteritic Ischemic Optic Neuropathy
Roma, Italy
View Trial DetailsNCT Number: NCT05305079
The purpose of the study is to use new diagnostic methods (OCT and OCT-A) to shed light on risk factors for the development of NA-AION. The risk factors we are focusing on are comorbidities along with anatomical and vascular characteristics of the optic nerve.
Looking for future studies?
Notify Me11 year and older
All sexes
Observational
Sydney Eye Hospital, Sydney, Australia
Non-arteritic anterior ischemic optic neuropathy (NA-AION) is the most common acute optic neuropathy in the middle-aged and elderly population and can also occur in children and young adults. NA-AION leads to irreversible vision loss, and there is currently no effective treatment. In recent years, acellular calcified deposits in the optic nerve head called optic disc drusen (ODD) have been investigated as an important risk factor for NA-AION in patients under the age of 50.
The purpose of the study is to use new diagnostic methods optical coherence tomography (OCT) and OCT-angiography (OCTA) to shed light on risk factors for the development of NA-AION. We will perform two sub-studies:
The study is an international prospective multicenter study including 20 sites in 9 different countries. The study population is patients diagnosed with NA-AION in a 1.5-year inclusion period. Each included patient gets 1-2 follow up visits during a 3-month follow up time.
Included patients will be examined as per standard clinical care for that site including OCT and OCT-A. Standard clinical care includes at least: obtaining medical history, measurement of visual acuity, slit lamp examination, and automated perimetry.
Characteristics and risk factors in NA-AION patients with ODD (ODD-AION) will be compared with NA-AOIN patients without ODD (nODD-AION).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: At enrollment
Presence of ODD. Diameter of the scleral canal, disc area and rim on each quadrant of the optic disc, thickness of the peripapillary choroid, presence of peripapillary hyperreflective ovoid mass-like structures, and prelaminar hyperreflective lines.
Time frame: 3-months follow-up visit
Presence of ODD. Diameter of the scleral canal, disc area and rim on each quadrant of the optic disc, thickness of the peripapillary choroid, presence of peripapillary hyperreflective ovoid mass-like structures, and prelaminar hyperreflective lines.
Time frame: 3-months follow-up visit
Transient versus persistent findings of ischemia, segmental location and extent of reduced vessel density. If ODD is present the vessel density will be compared to ODD location and volume.
Time frame: At 3-months follow-up visit
If ODD is present the volume and location of the ODD (superficial vs. deep) is measured using 3D-segmentation
Time frame: At enrollment
Assessed on Snellen or ETDRS chart
Time frame: 3-months follow-up visit
Assessed on Snellen or ETDRS chart
Time frame: At enrollment
Autoperimetry: SITA fast or standard 24-2
Time frame: 3-months follow-up visit
Autoperimetry: SITA fast or standard 24-2
Time frame: At enrollment
Score on questionnaire: National Eye Institute Visual Function Questionnaire 25 and 10-item Neuro-Ophthalmic Supplement
A vision-targeted composite score of the NEI-VFQ-25 together with the 10-item NO supplement score is calculated. The scale is 0-100 where a high score represents better functioning.
Time frame: 3-months follow-up visit
Score on questionnaire: National Eye Institute Visual Function Questionnaire 25 and 10-item Neuro-Ophthalmic Supplement.
A vision-targeted composite score of the NEI-VFQ-25 together with the 10-item NO supplement score is calculated. The scale is 0-100 where a high score represents better functioning.
Time frame: At enrollment
ischemic heart disease, stroke (ischemic or hemorrhagic), arterial hypertension, diabetes mellitus, end stage renal disease, smoking (now or previous), dyslipidemia, obstructive sleep apnea/continuous positive airway pressure (CPAP) use, phosphodiesterase-5 inhibitor use or ocular surgery.
Time frame: At enrollment
Spherical and cylindrical refraction. Measurements in diopters.
Time frame: At enrollment
Assessed on Ishihara or Hardy-Rand-Rittler plates. Measured as the fraction of how many correct plates out how many plates are used in the assessment in total. A score of 0 means no plates were read correctly and 1 means all plates were read correctly.
Time frame: 3-months follow-up visit
Assessed on Ishihara or Hardy-Rand-Rittler plates. Measured as the fraction of how many correct plates out how many plates are used in the assessment in total. A score of 0 means no plates were read correctly and 1 means all plates were read correctly.
Time frame: At enrollment
axial length of the eye in mm
Time frame: At enrollment
The curvature of the cornea in diopters
Rigshospitalet, Denmark
Other
Non-Arteritic Anterior Ischemic Optic Neuropathy Risk Factors: New Perspectives
Acronym: NARROW
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT03758118
Non-arteritic Ischemic Optic Neuropathy
Roma, Italy
View Trial DetailsNCT06031350
Non-arteritic Ischemic Optic Neuropathy
Al Fayyum, Egypt
View Trial DetailsNCT02045212
Cardiovascular Diseases, Cranial Nerve Diseases
Nahariya, Israel
View Trial DetailsNCT01614158
Non-arteritic Ischemic Optic Neuropathy
Tübingen, Baden-Wurttemberg, Germany
View Trial Details