No registrations found.
ID
Source
Brief title
Health condition
1. Glaucoma;
2. Ocular hypertension.
Sponsors and support
Schiedamsevest 180
3011 BH Rotterdam
Intervention
Outcome measures
Primary outcome
Sensitivity and specificity of glaucoma diagnostics (i.e. for glaucoma detection and for glaucoma progression detection).
Secondary outcome
N/A
Background summary
Rationale:
Glaucoma is the second leading cause of blindness in the world. Since glaucoma causes thinning of the nerve fiber layer prior to loss of vision, early detection may allow early treatment and, thus, prevent permanent loss of vision.
Objective:
Improving diagnostics for early detecting of (progression of) glaucoma.
Study design:
Longitudinal cohort.
Study population:
Glaucoma and ocular hypertension patients.
Intervention:
Hypotensive therapy.
Main study parameters/endpoints:
Sensitivity and specificity of glaucoma diagnostics.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: There are no anticipated major side effects associated with any of these measurements. The overall level of risk is similar to that of a full eye examination in a doctor's office. Burden is considered to be low.
Study objective
Structural imaging is more sensitive to early (progression) detection than functional measurements (i.e. visual fields).
Study design
Control visits as usual.
Intervention
Glaucoma group: careful follow-up with visual fields and structural imaging; no experimental intervention (care as usual).
Ocular hypertension groups: 3 arms (timolol, betaxolol and placebo eye drops), masked, randomized, prospective, placebo-controlled; careful follow-up with visual fields and structural imaging.
Schiedamsevest 180
H.G. Lemij
Schiedamsevest 180
Rotterdam 3011 BH
The Netherlands
+31 (0)10 4017777
Lemij@oogziekenhuis.nl
Schiedamsevest 180
H.G. Lemij
Schiedamsevest 180
Rotterdam 3011 BH
The Netherlands
+31 (0)10 4017777
Lemij@oogziekenhuis.nl
Inclusion criteria
1. Informed consent;
2. Glaucoma;
3. Ocular hypertension.
Exclusion criteria
1. Ocular opacifications (eg. of the cornea, lens etc.);
2. Nystagmus;
3. Significant other eye disorders (eg. age-related macular degeneration, other than mild cataract);
4. Systemic disease possibly affecting the eye (eg. systemic hypertension, diabetes);
5. Refractive errors larger than 10 D myopia or 5 D hyperopia.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL1152 |
| NTR-old | NTR1195 |
| Other | Oogziekenhuis Rotterdam, Schiedamsevest 180, 3011 BH Rotterdam : OZR-2000-06-II |
| ISRCTN | ISRCTN wordt niet meer aangevraagd |
Summary results
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2. Colen ThP, NEML Tang, PGH Mulder, HG Lemij. Sensitivity and specificity of new GDx parameters. Journal of Glaucoma 2004;13(1):28-33;<br>
<br><br>
3. Reus NJ, HG Lemij. The relationship between standard automated perimetry and GDx VCC measurements. Investigative Ophthalmology & Visual Science 2004;45(3):840-845;<br>
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4. Reus NJ, HG Lemij. Diagnostic accuracy of the GDx VCC for glaucoma. Ophthalmology 2004;111(10):1860-1865;<br>
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5. Reus NJ, HG Lemij. Scanning laser polarimetry of the retinal nerve fiber layer in perimetrically unaffected eyes of glaucoma patiënts. Ophthalmology 2004;111(12):2199-2203;<br>
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6. Tannenbaum DP, D Hoffman, HG Lemij, DF Garway-Heath, DS Greenfield, J Caprioli. Variable corneal compensation improves discrimination between normal and glaucomatous eyes with the scanning laser polarimeter. Ophthalmology 2004;111(2):259-264;<br>
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7. Colen TP, HG Lemij. Sensitivity and specifity of the GDx: clinical judgment of standard printouts versus the number. Journal of Glaucoma 2003;12(2):129-133;<br>
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8. Reus NJ, TP Colen, HG Lemij. Visualization of localized retinal nerve fiber layer defects with the GDx with individualized and with fixed compensation of anterior segment birefringence. Ophthalmology 2003;110(8):1512-1516;<br>
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9. Vermeer KA, Vos FM, Lemij HG, Vossepoel AM.`Detecting glaucomatous wedge shaped defects in polarimetric images. Med Image Anal. 2003;7(4):503-511.
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Burr JM, Botello-Pinzon P, Takwoingi Y, Hernández R, Vazquez-Montes
M, Elders A, Asaoka R, Banister K, van der Schoot J, Fraser C, King
A, Lemij H, Sanders R, Vernon S, Tuulonen A, Kotecha A, Glasziou P,
Garway-Heath D, Crabb D, Vale L, Azuara-Blanco A, Perera R, Ryan
M, Deeks J, Cook J. Surveillance for ocular hypertension: an evidence
synthesis and economic evaluation. Health Technol Assess. 2012;
16(29): 1-271. PMID: 22687263
<br><br>
Bryan SR, Vermeer KA, Eilers PH, Lemij HG, Lesaffre EM. Robust and Censored Modeling and Prediction of Progression in Glaucomatous Visual Fields. Invest Ophthalmol Vis Sci. 2013; 54(10): 6694-6700. PMID: 24030462