The Antioxidant Effect of Routine Vascular Therapy for Normal Tension Glaucoma Patients

NCT00465348 | Withdrawn

• 1 other identifier: 085-Mom-2007
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

To quantify oxidative stress in circulating leukocytes of normal tension glaucoma patients, prior to and one month after routine vascular therapy.

Conditions

Primary Open Angle Glaucoma

Keywords

normal tension glaucoma; vascular dysregulation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

primary open-angle glaucoma patients

You may qualify if:

• For NTG patients:
• A mean untreated intraocular pressure consistently equal to or below 21mmHg or median intraocular pressure equal to or below 20mmHg on diurnal testing (at least three measurements) with no single measurement greater than 24mmHg
• Open drainage angles on gonioscopy
• Typical optic disc damage with glaucomatous cupping and thinning of neuroretinal rim
• Visual field defect congruent to glaucomatous disc alteration
• No other pathological findings upon slit-lamp examination and indirect fundoscopy
• Vasospastic propensity will be assumed if a clear history of frequent cold hands (answering yes to the questions:" Do you always have cold hands, even during the summer time?" and "Do other people tell you that you have cold hands?") is reported.
• For healthy subjects:
• An intraocular pressure \< 20 mmHg
• No history of ocular or systemic disease
• No history of chronic or current systemic or topical medication, or of drug or alcohol abuse
• Normal blood pressure (100-140/60-90mm Hg)
• Best corrected visual acuity above 20/32 in both eyes
• No pathological findings upon slit-lamp examination and indirect fundoscopy

You may not qualify if:

• Iridocorneal angle extremely narrow with complete or partial closure as determined by gonioscopy
• Pigmentary dispersion or pseudoexfoliation
• Evidence for any secondary cause for a glaucomatous optic neuropathy (trauma, steroids, uveitis)
• History of chronic or recurrent severe inflammatory eye disease (eg. scleritis, uveitis) or clinically significant or progressive retinal disease (eg. diabetic retinopathy)
• History of ocular trauma or intraocular surgery within the past 6 months
• History of systemic infection or inflammation within the past 3 months
• Need for any concomitant medications that may interfere with the evaluation of leukocytes (eg: steroids, immunosuppressives)
• Patients with a significant history and /or active alcohol or drug abuse (significant is defined as that which may influence results of the study)

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Related Publications (1)

• Moenkemann H, Flammer J, Wunderlich K, Breipohl W, Schild HH, Golubnitschaja O. Increased DNA breaks and up-regulation of both G(1) and G(2) checkpoint genes p21(WAF1/CIP1) and 14-3-3 sigma in circulating leukocytes of glaucoma patients and vasospastic individuals. Amino Acids. 2005 Mar;28(2):199-205. doi: 10.1007/s00726-005-0169-x. Epub 2005 Jan 23.

  PMID: 15723242 BACKGROUND

Biospecimen

Retention: NONE RETAINED

plasma

MeSH Terms

Conditions

Glaucoma, Open-Angle; Low Tension Glaucoma

Condition Hierarchy (Ancestors)

Glaucoma; Ocular Hypertension; Eye Diseases; Optic Nerve Diseases

Study Officials

• Selim Orgül, MD

  University Hospital Basel, Eye Clinic

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2007
• First Posted: April 25, 2007
• Study Start: June 1, 2009
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: October 25, 2012

Record last verified: 2012-10