Feasibility of optical quality analysis system for the objective assessment of accommodation insufficiency: a phase 1 study.

Purpose: To assess differences in a new objective metric obtained with a double-pass technique between a group with accommodation insufficiency (AI) and a control group and to explore the diagnostic capabilities of this new tool in comparison to conventional procedures.

Methods: Retrospective cross-sectional case-control phase 1 study. Two groups with ages ranging from 8 to 18 years were recruited: AI and control group. The diagnostic criterion of AI was based on monocular accommodative amplitude (AA), 2 D below Hofstetter's calculation for minimum AA, and monocular accommodative facility (MAF), failing with minus lens and cut-off at ≤ 6 cycles per minute. Accommodative response with a double pass device (HD Analyzer, Visiometrics) was measured, performing an evaluation from +1.00 D to -3.50D (-0.5D steps), offering the width of the profile at 50% (WP) in minutes of arc.

Results: Differences were found between groups for the AA, MAF and MEM retinoscopy (p < 0.0001, p < 0.001, p = 0.037). The discriminative capacity of MEM retinoscopy for AI diagnosis was significant and the cut-off that maximized the sensitivity and specificity was > 0.5 D. Considering WP 50% in different points, the discriminative AI diagnosis capacities for the points of 2.0 D and 2.50 D were significant (ROC-AUC 0.78; p = 0.03 and p = 0.02).

Conclusions: Double-pass system metric differed between patients with AI and control group, therefore the aim of a Phase I study was achieved. Further steps with higher sample sizes are required to evidence if the system really provides any advantage versus conventional methods in the diagnosis of AI.