This K23 Award will allow the candidate to obtain the training and skills necessary to develop and lead patient-oriented research projects in pediatric ophthalmology, including multi-center clinical trials. The candidate will learn study design, protocol development, grant application, project management, data analysis, statistical methods, communication of results, and medical ethics. To achieve these objectives, the candidate will (1) work under the direct supervision of Dr. Roy Beck on several clinical trials conducted by the Pediatric Eye Disease Investigator Group, (2) obtain a masters degree in public health with a concentration in epidemiology and a minor in biostatistics, and (3) complete a research project with the guidance of Dr. Graham Quinn in retinopathy of prematurity (ROP), one of the leading causes of childhood blindness in the United States. The proposed research project will utilize digital retinal images to test our hypothesis that eyes with pre-plus disease (mild to moderately abnormal vascular dilation and tortuosity of central, posterior retinal blood vessels) are more likely to develop sight-threatening ROP.
The specific aims are (1) to investigate whether pre-plus predicts progression to severe ROP (threshold disease), (2) to determine if pre-plus adds predictive value beyond that already provided by established ROP descriptors of location (zone) and severity (stage), and (3) to study the natural history of pre-plus disease. To address these aims, 2 masked experts in ROP will grade the degree of vascular dilation and tortuosity in digital retinal images generated from video indirect ophthalmoscopy in a cohort of 150 infants. Eyes with pre-plus will be compared to normal eyes in regard to the proportion that progress to threshold. There are important clinical implications if pre-plus accurately predicts progression to threshold. These include improved ability to identify high-risk infants who may benefit from earlier than usual laser treatment, more effective screening protocols for some infants, and more accurate counseling of parents regarding the risk of disease progression.

Agency
National Institute of Health (NIH)
Institute
National Eye Institute (NEI)
Type
Mentored Patient-Oriented Research Career Development Award (K23)
Project #
5K23EY015806-05
Application #
7473815
Study Section
Special Emphasis Panel (ZEY1-VSN (06))
Program Officer
Everett, Donald F
Project Start
2004-08-01
Project End
2010-07-31
Budget Start
2008-08-01
Budget End
2010-07-31
Support Year
5
Fiscal Year
2008
Total Cost
$267,990
Indirect Cost
Name
Duke University
Department
Ophthalmology
Type
Schools of Medicine
DUNS #
044387793
City
Durham
State
NC
Country
United States
Zip Code
27705
Cabrera, Michelle T; Freedman, Sharon F; Hartnett, Mary Elizabeth et al. (2014) Real-time, computer-assisted quantification of plus disease in retinopathy of prematurity at the bedside. Ophthalmic Surg Lasers Imaging Retina 45:542-8
Wallace, David K; Freedman, Sharon F; Hartnett, M E et al. (2011) Predictive value of pre-plus disease in retinopathy of prematurity. Arch Ophthalmol 129:591-6
Cabrera, Michelle T; Freedman, Sharon F; Kiely, Amanda E et al. (2011) Combining ROPtool measurements of vascular tortuosity and width to quantify plus disease in retinopathy of prematurity. J AAPOS 15:40-4
Kiely, Amanda E; Wallace, David K; Freedman, Sharon F et al. (2010) Computer-assisted measurement of retinal vascular width and tortuosity in retinopathy of prematurity. Arch Ophthalmol 128:847-52
Wallace, David K; Freedman, Sharon F; Zhao, Zheen (2009) A pilot study using ROPtool to measure retinal vascular dilation. Retina 29:1182-7
Wallace, David K; Quinn, Graham E; Freedman, Sharon F et al. (2008) Agreement among pediatric ophthalmologists in diagnosing plus and pre-plus disease in retinopathy of prematurity. J AAPOS 12:352-6
Ahmad, Sukaina; Wallace, David K; Freedman, Sharon F et al. (2008) Computer-assisted assessment of plus disease in retinopathy of prematurity using video indirect ophthalmoscopy images. Retina 28:1458-62
Wallace, David K; Veness-Meehan, Kathleen A; Miller, William C (2007) Incidence of severe retinopathy of prematurity before and after a modest reduction in target oxygen saturation levels. J AAPOS 11:170-4
Wallace, David K (2007) Computer-assisted quantification of vascular tortuosity in retinopathy of prematurity (an American Ophthalmological Society thesis). Trans Am Ophthalmol Soc 105:594-615
Wallace, David K; Freedman, Sharon F; Zhao, Zheen et al. (2007) Accuracy of ROPtool vs individual examiners in assessing retinal vascular tortuosity. Arch Ophthalmol 125:1523-30