Trial reportBMC ophthalmology2025
Effectiveness and safety of a hydrophobic aspheric monofocal intraocular lens with molding process for cataract surgery.
Trial report in BMC ophthalmology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
1 citing paper in PubMed.
Corrections and comments
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Authors and funding
12 authors.
Funding
Abstract
backgroundTo evaluate the effectiveness and safety of a novel hydrophobic aspheric monofocal intraocular lens (IOL) in cataract surgery.
methodsThis is a prospective, multicenter, randomized, open-label, parallel-controlled clinical study, conducted at nine sites in P.R. China. Eligible participants were adults aged 60-80 years with a diagnosis of age-related cataract scheduled for phacoemulsification combined with IOL implantation. Subjects were randomly assigned to receive either the aspheric monofocal IOL (SM60AS, Henan Simedice Biotechnology Co. Ltd., Zhengzhou, China) or the control IOL (SN60WF Alcon Laboratories Inc.). Postoperative outcomes including uncorrected distance visual acuity (UDVA), best-corrected distance visual acuity (CDVA), refractive status, and complications were assessed and compared between the two groups at each follow-up visit.
resultsA total of 173 patients completed the study, including 88 in the SM60AS group and 85 in the SN60WF group. No statistically significant differences were found in CDVA between the two groups at any postoperative visit. Although the SM60AS group showed slightly lower UDVA at day 1, day 7 (p < 0.01) and 12 months (p < 0.05), there were no statistically significant differences in UDVA between the groups at 1, 3, and 6 months. The SM60AS group exhibited a slightly more myopic refractive outcome compared to the control group, while residual astigmatism remained comparable. No serious IOL-related complications were reported in either group.
conclusionThe novel SM60AS IOL demonstrated satisfactory effectiveness and safety, with clinical outcomes comparable to those of the established control IOL in cataract surgery.
trial registrationThe trial was officially registered on August 29, 2020, in the Chinese Clinical Trial Registry, with the registration number: ChiCTR2000037527 ( https://www.chictr.org.cn/showproj.html?proj=60164 ).
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