The primary specific aim of the OHTS II cohort study is to determine if there is a penalty for delaying treatment in ocular hypertension. The primary specific aim will be tested by comparing the long-term cumulative incidence of POAG and adverse events in the original observation participants in OHTS I who start treatment in OHTS II to the long-term cumulative incidence in medication participants who received medication throughout OHTS I and who continue treatment in OHTS II (Primary Specific Aim).
The specific aim of the Coordinating Center is to provide overall scientific leadership and operational support to accomplish the primary and secondary specific aims of OHTS II by: 1. Developing, distributing and maintaining a detailed Manual of Procedures 2. Training and certifying clinical staff in OHTS II study protocol and procedures 3. Monitoring adherence to the OHTS II protocol and providing feedback to clinic staff and resource centers 4. Ensuring collaboration between clinics and resource centers 5. Monitoring efficacy and safety at semi-annual intervals and as requested by the Data and Safety Monitoring Committee 6. Receiving, editing, storing and analyzing data from participating clinics, Visual Field Reading Center, Optic Disc Reading Center, Confocal Scanning Laser Ophthalmoscope Reading Center and the Short Wave Length Perimetry Reading Center. 7. Providing methodological and statistical expertise in the preparation of presentations and publications 8. Developing plans for the orderly close-out of the study including participants, clinics, and resource centers 9. Archiving and documenting study data.

Agency
National Institute of Health (NIH)
Institute
National Eye Institute (NEI)
Type
Cooperative Clinical Research--Cooperative Agreements (U10)
Project #
3U10EY009341-16S1
Application #
7917820
Study Section
Special Emphasis Panel (ZEY1-VSN (05))
Program Officer
Everett, Donald F
Project Start
2009-09-30
Project End
2012-09-29
Budget Start
2009-09-30
Budget End
2012-09-29
Support Year
16
Fiscal Year
2009
Total Cost
$1,301,816
Indirect Cost
Name
Washington University
Department
Ophthalmology
Type
Schools of Medicine
DUNS #
068552207
City
Saint Louis
State
MO
Country
United States
Zip Code
63130
Gao, Feng; Philip Miller, J; Xiong, Chengjie et al. (2017) Estimating correlation between multivariate longitudinal data in the presence of heterogeneity. BMC Med Res Methodol 17:124
Budenz, Donald L; Huecker, Julia Beiser; Gedde, Steven J et al. (2017) Thirteen-Year Follow-up of Optic Disc Hemorrhages in the Ocular Hypertension Treatment Study. Am J Ophthalmol 174:126-133
Scheetz, Todd E; Faga, Ben; Ortega, Lizette et al. (2016) Glaucoma Risk Alleles in the Ocular Hypertension Treatment Study. Ophthalmology 123:2527-2536
Gao, Feng; Miller, J Philip; Beiser, Julia A et al. (2015) Predicting Clinical Binary Outcome Using Multivariate Longitudinal Data: Application to Patients with Newly Diagnosed Primary Open-Angle Glaucoma. J Biom Biostat 6:
Song, Christian; De Moraes, Carlos Gustavo; Forchheimer, Ilana et al. (2014) Risk calculation variability over time in ocular hypertensive subjects. J Glaucoma 23:1-4
Anderson, Andrew J; Stainer, Matthew J (2014) A control experiment for studies that show improved visual sensitivity with intraocular pressure lowering in glaucoma. Ophthalmology 121:2028-32
Kummet, Colleen M; Zamba, K D; Doyle, Carrie K et al. (2013) Refinement of pointwise linear regression criteria for determining glaucoma progression. Invest Ophthalmol Vis Sci 54:6234-41
Gardiner, Stuart K; Demirel, Shaban; Gordon, Mae O et al. (2013) Seasonal changes in visual field sensitivity and intraocular pressure in the ocular hypertension treatment study. Ophthalmology 120:724-30
Gardiner, Stuart K; Demirel, Shaban; De Moraes, Carlos Gustavo et al. (2013) Series length used during trend analysis affects sensitivity to changes in progression rate in the ocular hypertension treatment study. Invest Ophthalmol Vis Sci 54:1252-9
Zangwill, Linda M; Jain, Sonia; Dirkes, Keri et al. (2013) The rate of structural change: the confocal scanning laser ophthalmoscopy ancillary study to the ocular hypertension treatment study. Am J Ophthalmol 155:971-82

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