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Randomized Controlled Trial
. 2019 Apr 23;19(1):93.
doi: 10.1186/s12886-019-1100-7.

LASIK-induced corneal changes after correction of hyperopia with and without application of Mitomycin-C

Ehab M Moawad  1 , Ahmed A Abd Elghany  2 , Amr A Gab-Alla  2 , Osama M Elbassiouny  2 , Mohsen S Badawy  2
Affiliations
Randomized Controlled Trial

LASIK-induced corneal changes after correction of hyperopia with and without application of Mitomycin-C

Ehab M Moawad et al. BMC Ophthalmol. .

Abstract

Background: The study aimed to assess the role of intraoperative mitomycin-C (MMC) application during hyperopic LASIK correction (+ 1.00 D to + 6.00 D) by examining topographic corneal changes and incidence of regression over a one-year follow-up period.

Methods: This comparative randomized control study included 68 hyperopic patients (136 eyes) divided into two groups; Group A included 34 patients (68 eyes) that had LASIK with the application of 0.02% MMC for 10 s on the stromal bed after excimer laser treatment, and group B included 34 patients (68 eyes) that had LASIK without MMC application. Uncorrected distance visual acuity (UDVA), refraction, keratometry and topography were recorded at 1st week and 1st, 3rd, 6th, and 12th months postoperation. Predictability and treatment efficacy were also recorded at the end of the follow-up period.

Results: Better predictability was noted in group A than in group B at the 6 month and 12 month follow-up visits, with a mean cycloplegic refraction SE of + 0.5 ± 0.31 D in group A and + 0.67 ± 0.39 D in group B at the 6 month visit, and + 0.63 ± 0.37 D in group A and + 0.89 ± 0.48 D in group B at the 12 month visit. The efficacy of the treatment at the end of the follow up period was better in group A than in group B. Group A showed fewer topographic corneal changes than group B.

Conclusions: Intraoperative MMC application during hyperopic LASIK achieves better predictability and efficacy and induces fewer topographic changes and lower regression rate of hyperopia during the first postoperative year.

Trial registration: the Pan African Clinical Trial Registry PACTR201901543722087 , on 29 January 2019.

Keywords: Hyperopic LASIK - regression; Mitomycin-C.

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Conflict of interest statement

Ethics approval and consent to participate

Informed written consent was obtained from all study individuals. This study was approved by the Departmental Research Committee and Research Ethics Committee, Faculty of medicine, Suez Canal University on (14/2/2016) with a reference number (research #2717) and followed the tenets of Declaration of Helsinki.

Consent for publication

Consent for the publication of identifying images or other personal or clinical details of participants that compromise anonymity is not applicable.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Change in UDVA (decimal) over 12 months postoperation in both study groups
Fig. 2
Fig. 2
Change in corneal thickness (μm) over 12 months postoperation in both study groups was measured by the difference in the mean corneal thickness at the 6–mm optical zone at 12 months and 1 week postoperation
Fig. 3
Fig. 3
Change in keratometry (D) over 12 months postoperation in both study groups was measured by the difference in keratometry at 12 months and 1 week postoperation
Fig. 4
Fig. 4
Treatment efficacy in the two study groups was assessed by number of lines of decimal gained or lost at the end over 12 months postoperation
Fig. 5
Fig. 5
Regression in each subgroup regarding the amount of hyperopic correction
Fig. 6
Fig. 6
Treatment efficacy in the two low to moderate hyperopia subgroups was assessed by number of lines of decimal gained or lost at the end over 12 months postoperation
Fig. 7
Fig. 7
Treatment efficacy in the two high hyperopia subgroups was assessed by number of lines of decimal gained or lost at the end over 12 months postoperation
See this image and copyright information in PMC

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