[Clinical observation on corneal transparency after small incision lenticule extraction surgery]

Objective: To evaluate the changes of corneal transparency over the 1-year period after small incision lenticule extraction (SMILE) according to corneal Scheimpflug densitometry. Methods: Prospective cohort study. Fifty-five patients (100 eyes) with myopia (19 male and 36 female, aged 18 to 39 years with average of 24) who underwent SMILE and regular follow-up for at least 1 year at Tianjin Eye Hospital were enrolled. Examinations took place before SMILE and postoperatively at 1 day, 1 week, and 1, 3, 6, and 12 months. The preoperative spherical equivalent of surgical refractive correction was (-5.75±1.64) D. Corneal densitometry (CD) data were calculated automatically by the Pentacam Scheimpflug system and expressed in gray scale units (GSU), from 0 (completely transparent) to 100 (completely opaque). During the analysis of corneal densitometry, the average corneal optical density of three concentric radial zones centered on the apex of the cornea ≤2 mm, >2 mm and ≤6 mm, >6 mm and ≤10 mm diameter) were applied, and three layers were defined according to different corneal depths (the anterior 120 μm as 1st layer, and the posterior 60 μm as 3rd layer, and the center part between them of the cornea as 2nd layer). The automatic release mode was applied in order to avoid operator-induced errors. The preoperative and postoperative values in different corneal layers and different concentric radial zones were compared using Kruskal-Wallis. Results: Ninty-three eyes(93%) of all eyes achieved uncorrected distance visual acuity (UCVA) of 0.8 or better on the first day postoperatively, and 96% (96 of 100 eyes) achieved UCVA of 0.8 or better in the first week postoperatevely, and all eyes 100% (100 of 100 eyes) achieved UCVA 0.8 or better until the end of our follow-up (in 1 year postoperatively). In general, the difference preoperative and postoperative corneal average optical density is of no statistical significance (χ(2)=8.446, P=0.207), specifically, the overall postoperative CD increased in the first week after surgery (1 day to 15.90, 1 week to 15.65), and then decreased to the equivalent of baseline levels and maintained such level until 6 months after surgery (1 month to 15.60; 3 month to 15.50, 6 month to 15.55), though at the 12-month follow-up, densitometry values had spiked significantly again (12 month, 15.90). The difference between the preoperative and postoperative CD values in the central two zones (≤2 mm, >2 mm and ≤6 mm), but not the outer (>6 mm and ≤10 mm), were of statistical significance (χ(2)=61.961, 52.397, P<0.000). When subdivided by corneal layer, significant changes in CD were detected in the anterior 120 μm layer (χ(2)=27.774, P<0.000). The CD increased significantly (i.e., corneal transparency decreased) as compared to the preoperative baseline on the first postoperative day, and lasted through the first week. There were no significant changes in the CD of the central layer (χ(2)=0.918, P=0.986). Significant increases in the posterior 60 μm of the cornea after surgery were found only at the 6-month and 1-year follow-up examinations (χ(2)=17.469, P=0.008). No correlation was found in the preoperative refractive error, ablation depth, postoperative UCVA and the CD. The CD at 6 months was found negatively correlated with SE at 6 months (r=-0.219, P=0.028). Conclusions: SMILE reduced corneal transparency temporarily and primarily within the surgically altered area, however such change has no significant correlation with the ablation depth, SE, and the postoperative UCVA. Transparency recovered within a month, but patients should be monitored for at least 1 year. (Chin J Ophthalmol, 2018, 54: 27-32).