Status:
COMPLETED
Neural Conduction Along the Visual Pathways After Oral Treatment With Citicoline in Patients With Optic Nerve Diseases
Lead Sponsor:
Fondazione G.B. Bietti, IRCCS
Conditions:
Glaucoma
Optic Neuropathy, Ischemic
Eligibility:
All Genders
40-70 years
Phase:
PHASE4
Brief Summary
In the management of glaucoma, as for as in other optic nerve diseases, an important goal of ophthalmologists is represented by the possibility of influencing visual function. In this regard, Parisi ...
Detailed Description
Participants: 30 patients with open-angle glaucoma (OAG) and 15 patients (mean age 64.6±3.3ys) with non-arteritic ischemic optic neuropathy (NION) were enrolled enrolled. Ten OAG patients will be unt...
Eligibility Criteria
Inclusion
- Glaucoma Patients:
- IOP \> 23 mmHg and \< 28 mmHg (average of the two highest readings of the daily curve, from 8:00 a.m. to 6:00 p.m., six independent readings, one every two hours) without medical treatment;
- HFA with MD \< - 2 dB; CPSD \> +2 dB; fixation losses, false positive rate and false negative rate each less than 20%;
- best corrected visual acuity of 20/20 or better;
- one or more papillary signs on conventional color stereo-slides: the presence of a localized loss of neuroretinal rim (notch), thinning of the neuroretinal rim, generalized loss of optic rim tissue, optic disc excavation, vertical or horizontal cup/disc ratio greater than 0.5, cup-disc asymmetry between the two eyes greater than 0.2, peripapillary splinter hemorrhages;
- refractive error (when present) between -1.00 and +1.00 spherical equivalent;
- no previous history or presence of any disease involving cornea, lens, macula or retina;
- no previous history or presence of diabetes, optic neuritis, any disease involving the visual pathways;
- pupil diameter \> 3 mm without mydriatic or miotic drugs.
- Patients with non-arteritic ischemic optic neuropathy:
- IOP \< 21 mmHg HFA with MD \< - 2 dB; CPSD \> +2 dB; fixation losses, false positive rate and false negative rate each less than 20%;
- refractive error (when present) between -1.00 and +1.00 spherical equivalent;
- no previous history or presence of any disease involving cornea, lens, macula or retina;
- no previous history or presence of diabetes of any further disease involving the visual pathways;
- pupil diameter \> 3 mm without mydriatic or miotic drugs.
Exclusion
- All other condition that may influence Visual Evoked Potentials:
- \- previous history or presence of any disease involving cornea, lens, macula or retina or optic nerve (i.e inflammatory diseases)
Key Trial Info
Start Date :
February 28 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 30 2006
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00404729
Start Date
February 28 2005
End Date
July 30 2006
Last Update
February 3 2021
Active Locations (2)
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1
Fondazione G.B. Bietti- IRCCS
Rome, Italy, 00199
2
Fondazione G.B. Bietti-IRCCS
Rome, Italy, 00199