Retinal Visualization In A Small Aperture Iol Treated Eye

To evaluate the ability to perform retinal fundus photography, SD-OCT imaging, and visual field testing in eyes treated with a small aperture IOL.

Multicenter clinical ophthalmology practice

Subjects in the US Clinical trial for the IC-8 small aperture IOL were enrolled into one of two groups. The IC-8 Group (n=343) was implanted with a monofocal or monofocal toric IOL in their first eye, targeted to plano, and an IC-8 IOL in their second eye, targeted to -0.75 D residual refraction. The Control Group (N=110) patients were bilaterally treated with monofocal or monofocal toric IOLs targeting plano. The Retinal Diagnostic Testing subgroup included 49 subjects at 2 investigational sites.  Dilated fundus photography, dilated SD-OCT, and undilated visual field images were evaluated preoperatively and at 3 months postoperatively. The quality of the testing was graded by the Investigators and by the Fundus Photography Reading Center.

The investigators rated 100% of the fundus photos and SD-OCT image quality and as excellent or adequate at baseline and 3 Months regardless of pupil size (≤7mm, >7mm to <9mm, and ≥9mm). The Fundus Photography Reading Center graded fundus photos and SD-OCT images with a high or adequate confidence score in >90% in study eyes at baseline and 3 Months.  Visual Field testing showed no change from baseline to 3 Months in the majority of IC-8 eyes (75.5%) while 69.4% of the fellow monofocal eyes had no change from baseline. When looking at the Mean Deviation (MD) scores, the IC-8 eyes had a change in MD of 0.207 and the fellow monofocal eyes had a MD change of 0.791.

Retinal fundus photography, SD-OCT imaging, and visual field testing can be reliably performed in eyes treated with a small-aperture IOL.