Prospective, single-center, interventional follow-up study to determine the effect of prostate carcinoma and its operative therapy on intraocular pressure and determination of potential mediators.
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ABSTRACT: Interventions: Group 1: Patients with prostate cancer and planned radical prostatectomy
Contact-free examinations:
x. Determination of refraction and visual acuity
xi. Slit lamp finding (phak / pseudophak), anomalies of the anterior segment affecting the measurability or height of the IOD
xii. Pupillometry (pupil width with and without glare, medically unaffected, possibly latency, constriction and dilatation rate)
xiii. HRT for glaucoma exclusion
xiv. Visante-OCT for corneal thickness measurement
Examinations with contact to the eye
xv. Intraocular pressure using Pascal tonometer and time of measurement (preferably at 03:00pm +/- 1 hour)
xvi. Intraocular pressure using Goldmann tonometer and time of measurement (preferably at 03:00pm +/- 1 hour)
Other investigations
xvii. Blood sample (if possible, combine with clinical routine blood sampling at the Department of Urology)
xviii. urine sample
Group 2: Patients without cancer
Contact-free examinations:
x. Determination of refraction and visual acuity
xi. Slit lamp finding (phak / pseudophak), anomalies of the anterior segment affecting the measurability or height of the IOD
xii. Pupillometry (pupil width with and without glare, medically unaffected, possibly latency, constriction and dilatation rate)
xiii. HRT for glaucoma exclusion
xiv. Visante-OCT for corneal thickness measurement
Examinations with contact to the eye
xv. Intraocular pressure using Pascal tonometer and time of measurement (preferably at 03:00pm +/- 1 hour)
xvi. Intraocular pressure using Goldmann tonometer and time of measurement (preferably at 03:00pm +/- 1 hour)
Other investigations
xvii. Blood sample (if possible, combine with clinical routine blood sampling at the Departme
Primary outcome(s): Does the intraocular pressure differ between patients with prostate cancer and a healthy comparison group? Does the intraocular pressure in prostate cancer, breast cancer or colorectal cancer patients change after surgical tumor removal compared to preoperative values? Is there a difference in systemic levels of potential chemical mediator between prostate cancer patients and a healthy comparison group? Do the absolute values and their postoperative change correlate with the intraocular pressure?
After completing the recruitment, the data of all four patient groups are evaluated with the program STATISTICA (StatSoft).
Study Design: Allocation: Non-randomized controlled study; Masking: Open (masking not used); Control: Other; Assignment: parallel; Study design purpose: diagnostic
DISEASE(S): Primary Open-angle Glaucoma,Prostate Cancer, Mamma Carcinoma, Colorectal Carcinoma
PROVIDER: 2434903 | ecrin-mdr-crc |
REPOSITORIES: ECRIN MDR
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