What this study is
The purpose of this study is to improve understanding of the pathophysiologic process that leads to the development of glaucamotous damage. The mechanism by which vision loss in glaucoma occurs is still unknown, but it is clear that increased intraocular pressure (IOP) is a major risk factor. It is also thought that the LC is a site of primary damage during pathogenesis of the disease. This prospective study with determine the in-vivo mechanical response to IOP modulation at the level of the ONH and LC.
What's being tested
- Increasing of intraocular pressure (IC)
Intervention · DIAGNOSTIC TEST
intraocular pressure will be increased using an ophthalmodynanometer
Study details
- Official title
- Effects of Elevated Intraocular Pressure on the Lamina Cribrosa
- Sponsor
- NYU Langone Health
- Conditions
- Intraocular Pressure
- Enrolling
- 150 people
- Starts
- 2018-03-07
- Est. completion
- 2024-05-08
- Design
- Open-label, non-randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 90 YearsSex ALLHealthy volunteers AcceptedYou may qualify if
- Healthy volunteers
- No family history (first degree relative) of glaucoma.
- No history of IOP >22 mmHg.
- Normal appearing optic discs and RNFL on dilated fundus examination.
- Normal Swedish interactive thresholding algorithm (SITA) standard perimetry tests as defined by glaucoma hemifield test (GHT) within normal limits. Glaucoma suspects
- Normal visual field as defined above.
- Either IOP between 25 to 30 mmHg with central corneal thickness < 550µm, or a difference ≥ 0.2 in cup to disc ratio between eyes. Glaucoma
- Glaucomatous ONH abnormality: rim thinning, notching, undermining (excavation) or diffuse or localized RNFL defects that are characteristic of glaucoma.
- Two consecutive abnormal SITA standard perimetry tests with GHT outside normal limits.
You can't join if
- Media opacity (e.g. lens, vitreous, cornea).
- Strabismus, nystagmus or a condition that would prevent fixation.
- Diabetes with evidence of retinopathy.
- Previous intraocular surgery or ocular trauma (with the exception of laser procedures and subjects that have undergone uneventful cataract surgery more than 6 months from enrollment date).
- Neurological and non-glaucomatous causes for visual field damage.
- Any intraocular non-glaucomatous ocular disorders.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openNYU Langone Health
New York, New York, United States
- Jamika Singleton-Garvin · Contact929-455-5522Jamika.Singleton-Garvin@nyulangone.org
- Gadi Wollstein, MD · Principal investigator
Recruiting
Study team
Sponsor
NYU Langone Health
Study ID 17-01027
Principal investigator
Gadi Wollstein, MD
NYU Langone Health
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.