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Voortzetting Follow-Up Imaging Onderzoek bij Glaucoom en Oculaire Hypertensie.


- candidate number2999
- NTR NumberNTR1195
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR10-jan-2008
- Secondary IDsOZR-2000-06-II Oogziekenhuis Rotterdam, Schiedamsevest 180, 3011 BH Rotterdam
- Public TitleVoortzetting Follow-Up Imaging Onderzoek bij Glaucoom en Oculaire Hypertensie.
- Scientific TitleFollow-up of glaucoma and ocular hypertension patients with improved imaging techniques.
- ACRONYMN/A
- hypothesisStructural imaging is more sensitive to early (progression) detection than functional measurements (i.e. visual fields).
- Healt Condition(s) or Problem(s) studiedGlaucoma, Ocular hypertension
- Inclusion criteria1. Informed consent;
2. Glaucoma;
3. Ocular hypertension.
- Exclusion criteria1. 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.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jan-2000
- planned closingdate31-aug-2008
- Target number of participants685
- InterventionsGlaucoma 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.
- Primary outcomeSensitivity and specificity of glaucoma diagnostics (i.e. for glaucoma detection and for glaucoma progression detection).
- Secondary outcomeN/A
- TimepointsControl visits as usual.
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESDr. H.G. Lemij
- CONTACT for SCIENTIFIC QUERIESDr. H.G. Lemij
- Sponsor/Initiator Oogziekenhuis Rotterdam (OZR)
- Funding
(Source(s) of Monetary or Material Support)
Stichting Wetenschappelijk Onderzoek het Oogziekenhuis
- Publications1. Reus NJ, Lemij HG. Relationships between Standard Automated Perimetry, HRT Confocal Scanning Laser Ophthalmoscopy, and GDx VCC Scanning Laser Polarimetry. Invest Ophthalmol Vis Sci. 2005;46(11):4182-8;


2. Colen ThP, NEML Tang, PGH Mulder, HG Lemij. Sensitivity and specificity of new GDx parameters. Journal of Glaucoma 2004;13(1):28-33;


3. Reus NJ, HG Lemij. The relationship between standard automated perimetry and GDx VCC measurements. Investigative Ophthalmology & Visual Science 2004;45(3):840-845;


4. Reus NJ, HG Lemij. Diagnostic accuracy of the GDx VCC for glaucoma. Ophthalmology 2004;111(10):1860-1865;


5. Reus NJ, HG Lemij. Scanning laser polarimetry of the retinal nerve fiber layer in perimetrically unaffected eyes of glaucoma patiŽnts. Ophthalmology 2004;111(12):2199-2203;


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;


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;


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;


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.

Burr JM, Botello-Pinzon P, Takwoingi Y, HernŠndez 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

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
- Brief summaryRationale:
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.
- Main changes (audit trail)
- RECORD10-jan-2008 - 12-sep-2014


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