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| The Safety and Efficacy of Scleral Lenses in the Treatment of Ametropia Compared with Rigid Gas-Permeable Contact Lenses |
| Qianni Jiang1, Bichi Chen2, Jiaqi Zhou3, Li Zeng3, Feng Xue3, Ruihua Wei1, Zhi Chen3 |
| 1Tianjin Key Laboratory of Retinal Functions and Diseases, Tianjin Branch of National Clinical Research Center for Ocular Disease, Eye Institute and School of Optometry, Tianjin Medical University Eye Hospital, Tianjin 300384, China 2Shanghai Vision X Medical Technology Co., Ltd, Shanghai 200240, China 3Department of Ophthalmology, Fudan University Eye and ENT Hospital, Shanghai 200031, China |
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Abstract Objective: To compare the safety and efficacy of scleral lenses (SLs) and rigid gas-permeable contact lenses (RGPCLs) in the treatment of ametropia in adults. Methods: Aprospective randomized controlled trail was conducted at Fudan University Eye and ENT Hospital between July 2021 and February 2022. A total of 41 ametropic adults (41 eyes) were enrolled in the study. The participants were randomly assigned to either the control group (RGPCL group) or the intervention group (SL group) using a computerized block group randomization method. The RGPCL group consisted of 21 myopic adults (21 eyes) and the SL group consisted of 20 myopic adults (20 eyes). Follow-up visits were scheduled at 1 week, 1 month and 3 months after lens dispensing. The following parameters were compared between the two groups: corrected distance visual acuity (CDVA), ocular complications, corneal endothelial cell density (ECD) and polymorphonuclear changes (ECPC), corneal central thickness (CCT), intraocular pressure (IOP) and subjective acceptability scores. Only data from the right eyes were included in the analysis. Repeated measures ANOVA, paired t-test, Mann-Whitney U test, Wilcoxon signed ranks test and Friedman test were used for statistical analysis. Results: There was no statistically signifcant difference in CDVAand IOP between the two groups at the lens dispensing visit, 1 week, 1 month and 3-month visits (all P>0.05). Likewise there was no statistically signifcant difference in ECD, ECPC and CCT between the two groups at 3-month visit (all P>0.05). The scores of subjective comfort and subjective visual quality also did not differ signifcantly between the groups (all P>0.05). However, subjects reported lower levels of operability for the SLs compared to the RGPCLs at the lens dispensing visit, 1 month and 3-month visits (Z=2.38, P=0.017; Z=2.72, P=0.007; Z=3.70, P<0.001). Regarding cleanability scores, the SL group scored slightly lower than the RGPCL group after 3 months, and this difference was statistically significant (Z=2.88, P=0.004). No lens-related ocular complications were found in either group during the follow-up period.Conclusions: In adults, SLs provide good and consistent correction of vision compared to RGPCLs. Additionally, SLs were found to be safe for short-term use.
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Received: 06 March 2023
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| Fund:Tianjin Key Medical Discipline (Specialty) Construction Project (TJYXZDXK-037A) |
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Corresponding Authors:
Zhi Chen, Email: peter459@aliyun.com
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