Abstract
Purpose :
To evaluate subjective visual function outcomes, 6 months after implantation of Intracorneal Ring Segments (Intacs®), followed by corneal collagen cross-linking (CXL) therapy for keratoconus.
Methods :
Patients with were enrolled as part of a prospective, randomized, controlled clinical trial (#NCT0111072) performed under a physician-sponsored Investigational New Drug. Patients were randomized to one of two groups: Intacs placement, immediately followed by CXL during the same session, or Intacs placement followed by crosslinking 3 months later. This study was a secondary analysis performed on the entire cohort of patients. Patients completed the Visual Function Questionnaire 25 (VFQ-25) preoperatively, and at 1, 3, and 6 months postoperatively as well. The responses were converted to a 0 to 100 scale (0=worst, 100=best), and the responses were compared using a paired two tailed t test (P<0.05).
Results :
One hundred eighty patients underwent Intacs and CXL procedures concurrently or three months apart. Preoperatively, patients reported a VFQ 25 score of 59.8+/-38.2, 24.6+/-31.1, 35.5+/-19.6, 53.3+/-27.8, 50.7+/-33.2, 39.2+/-34.2, 90.5+/-24.3, 59.6+/-41.5, 75.1+/-32.6, 32.8+/-21.6, 28.1+/-30.5, 21.8+/-24.8, for general health, general vision, ocular pain, distance activities, near activities, driving, color vision, peripheral vision, social functioning, mental health, role difficulties, and dependency, respectively. At 6 months postoperatively patients reported an improvement in general vision (17.5+/-44.6,p<0.01), ocular pain (4.0+/-20.1, p=0.01), distance activities (12.4+/-29.0, p<0.01), near activities (4.0+/-15.1,p<0.01), driving (9.5+/-35.0, p<0.01), color vision (3.6+/-24.0, p=0.04), peripheral vision (15.4+/-45.1, p=0.01), and social functioning (5.4+/-28.2, P<0.01). Additionally, patients reported no significant change in their general health (-3.7+/-36.4, p=0.18), and a worsening of their mental health (-6.7+/-19.8, p<0.01), role difficulties (-11.4+/-29, p<0.01), and dependency (-2.1+/-8.4, p<0.01), 6 months after combination therapy.
Conclusions :
Six months after the combination of Intacs and CXL therapy, patients reported an improvement in most aspects of their visual function. However, patients did report a worsening of their mental health, role difficulties, and dependency. This may be related to preoperative patient expectations after surgery.
This abstract was presented at the 2019 ARVO Annual Meeting, held in Vancouver, Canada, April 28 - May 2, 2019.