The confocal scanning laser ophthalmoscopy ancillary study to the ocular hypertension treatment study: Study design and baseline factors

Abstract Purpose To describe the study design of the Confocal Scanning Laser Ophthalmoscopy (CSLO) Ancillary Study to the Ocular Hypertension Treatment Study (OHTS) and to examine the associations between optic disk topography, and baseline demographic, clinical, and ocular factors at study entry. Design A randomized clinical trial. Methods Participants in this ancillary study were recruited from seven of the 22 OHTS clinical centers. Each participant completed imaging annually using a CSLO, the Heidelberg Retina Tomograph (HRT). Associations between HRT topographic optic disk measurements and intraocular pressure (IOP), baseline photographic estimates of horizontal and vertical cup-to-disk diameter ratios by the OHTS Optic Disk Reading Center, baseline visual field indices, and demographic and clinical factors were assessed using linear mixed effects models. Results Four hundred thirty-nine participants had good quality images and were included in this baseline analysis. No associations between HRT topographic optic disk measurements and diabetes, systemic hypertension, cardiovascular disease, IOP, or visual function were found. The HRT topographic optic disk measurements were associated with baseline stereophotographic estimates of horizontal and vertical cup-to-disk diameter ratios. The strongest associations were found between stereophotographic assessment of horizontal and vertical cup-to-disk diameter ratios, and HRT cup-to-disk area ratio ( r = .85 and .84, respectively), rim-to-disk area ratio ( r = −.85 and −.84, respectively), mean cup depth ( r = .84 and .83, respectively), and cup area ( r = .83 and .80, respectively). After adjusting for optic disk area, all HRT topographic optic disk measurements remained associated with stereophotographic assessment of horizontal and vertical cup-to-disk diameter ratios. Conclusions The CSLO ancillary study to the OHTS is the first multicenter clinical trial to use CSLO imaging to monitor changes in the optic disk. At study entry, HRT topographic measurements corresponded well with both horizontal and vertical stereophotographic-based estimates of cup-to-disk diameter ratio in ocular hypertensive participants.