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双侧等焦点光学设计或单焦点人工晶状体的前瞻性随机单盲研究。

Prospective Randomized Single-Masked Study of Bilateral Isofocal Optic-Design or Monofocal Intraocular Lenses.

作者信息

Ang Robert Edward T, Stodulka Pavel, Poyales Francisco

机构信息

Cataract and Refractive Surgery Department, Asian Eye Institute, Makati City, Philippines.

Cataract and Refractive Surgery Department, Gemini Eye Clinic, Zlín and Gemini Eye Clinic, Prague, Czech Republic.

出版信息

Clin Ophthalmol. 2023 Aug 4;17:2231-2242. doi: 10.2147/OPTH.S425352. eCollection 2023.

DOI:10.2147/OPTH.S425352
PMID:37559778
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10408699/
Abstract

PURPOSE

To assess refractive and visual outcomes of bilateral implantation of an isofocal optic-design intraocular lens (IOL) or a monofocal IOL following cataract surgery.

METHODS

A total of 127 patients were recruited into a prospective, single-masked, randomized trial. Sixty-five patients bilaterally implanted with the Isopure Isofocal IOL and 62 patients with the Micropure Monofocal IOL were followed for 4-6 months. Refraction, monocular and binocular uncorrected-distance-visual acuity, corrected-distance-visual acuity (CDVA), uncorrected-intermediate-visual acuity and distance-corrected-intermediate-visual acuity (DCIVA, 66/80 cm), uncorrected-near-visual acuity, and distance-corrected-near-visual acuity (DCNVA, 40 cm) were evaluated. Binocular defocus curve, binocular contrast sensitivity (photopic, mesopic with/without glare), and glare and halo phenomena were also measured.

RESULTS

99.23% of eyes were within ±1.00D and 84.62% of eyes within ±0.50D for the Isopure patients and 98.39% and 82.26% for the Micropure patients, respectively. The mean spherical-equivalent was -0.06 ± 0.36D and 0.10 ± 0.32D for the Isopure and Micropure patients, respectively. 98.5% and 100% of patients implanted with the Isopure and Micropure IOLs showed a cumulative binocular CDVA value ≥20/20, respectively. 80% and 67.70% of patients implanted with the Isopure presented a binocular DCIVA ≥20/25 at 80 and 66 cm, respectively. These percentages were 46.8% and 40.3% with the Micropure IOL, respectively. For Isopure, 7.7%, 30.8%, and 58.5% of patients presented a DCNVA ≥20/25, ≥20/32 and ≥20/40, respectively. These values were lower for the Micropure: 1.6%, 19.4% and 46.8%, respectively. Defocus curves showed similar good visual acuity at distance for both lenses with better intermediate vision for the Isopure. Both groups presented good contrast sensitivity, and the size and intensity of halo and glare phenomena were similar between the two. No adverse-events were reported.

CONCLUSION

Our trial shows that both IOLs provide excellent visual acuity and contrast sensitivity for far vision with similar photic phenomena, and the Isopure IOL improved unaided intermediate vision performance.

摘要

目的

评估白内障手术后双侧植入等焦点光学设计人工晶状体(IOL)或单焦点IOL的屈光和视觉效果。

方法

127例患者被纳入一项前瞻性、单盲、随机试验。65例双侧植入Isopure等焦点IOL的患者和62例植入Micropure单焦点IOL的患者随访4 - 6个月。评估了屈光、单眼和双眼未矫正远视力、矫正远视力(CDVA)、未矫正中视力和距离矫正中视力(DCIVA,66/80 cm)、未矫正近视力以及距离矫正近视力(DCNVA,40 cm)。还测量了双眼散焦曲线、双眼对比敏感度(明视、有无眩光的间视)以及眩光和光晕现象。

结果

对于植入Isopure的患者,99.23%的眼在±1.00D范围内,84.62%的眼在±0.50D范围内;对于植入Micropure的患者,这两个比例分别为98.39%和82.26%。植入Isopure和Micropure的患者平均球镜等效度数分别为 - 0.06±0.36D和0.10±0.32D。植入Isopure和Micropure IOL的患者分别有98.5%和100%的累积双眼CDVA值≥20/20。植入Isopure的患者分别有80%和67.70%在80 cm和66 cm处双眼DCIVA≥20/25。使用Micropure IOL时,这些百分比分别为46.8%和40.3%。对于Isopure,分别有7.7%、30.8%和58.5%的患者DCNVA≥20/25、≥20/32和≥20/40。Micropure的这些值较低,分别为1.6%、19.4%和46.8%。散焦曲线显示两种晶状体在远视力方面的视力相似,而Isopure在中视力方面表现更好。两组对比敏感度均良好,两组间光晕和眩光现象的大小及强度相似。未报告不良事件。

结论

我们的试验表明,两种IOL在远视力方面均提供了出色的视力和对比敏感度,且有相似的光学现象,并且Isopure IOL改善了非辅助中视力表现。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9c58/10408699/711bb5a51133/OPTH-17-2231-g0007.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9c58/10408699/d9f7137d1b48/OPTH-17-2231-g0001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9c58/10408699/70f92f5e4e4a/OPTH-17-2231-g0002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9c58/10408699/b0a78a874861/OPTH-17-2231-g0003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9c58/10408699/14bd29d5749b/OPTH-17-2231-g0004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9c58/10408699/732c27c5cb32/OPTH-17-2231-g0005.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9c58/10408699/ffe95ceddf31/OPTH-17-2231-g0006.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9c58/10408699/711bb5a51133/OPTH-17-2231-g0007.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9c58/10408699/d9f7137d1b48/OPTH-17-2231-g0001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9c58/10408699/70f92f5e4e4a/OPTH-17-2231-g0002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9c58/10408699/b0a78a874861/OPTH-17-2231-g0003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9c58/10408699/14bd29d5749b/OPTH-17-2231-g0004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9c58/10408699/732c27c5cb32/OPTH-17-2231-g0005.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9c58/10408699/ffe95ceddf31/OPTH-17-2231-g0006.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9c58/10408699/711bb5a51133/OPTH-17-2231-g0007.jpg

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