Visual, clinical and quality of life outcomes of a new multifocal IOL with optimized diffractive grating: a non-randomized clinical trial
Abstract Background Multifocal intraocular lenses (IOLs) are designed to reduce dependence on spectacles by providing multiple focal points. However, they are associated with photic phenomena such as halos and glare, and may reduce contrast sensitivity. The BIOS Trifocal is a single-piece acrylic di...
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BMC
2025-02-01
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| Series: | BMC Ophthalmology |
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| Online Access: | https://doi.org/10.1186/s12886-025-03878-3 |
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| author | João Marcelo de Almeida Gusmão Lyra Mariana Silva Gois de Almeida Lucila de Albuquerque Barbosa Lira Laís Oliveira dos Santos Mateus Lins dos Santos Jorge Artur Peçanha de Miranda Coelho |
| author_facet | João Marcelo de Almeida Gusmão Lyra Mariana Silva Gois de Almeida Lucila de Albuquerque Barbosa Lira Laís Oliveira dos Santos Mateus Lins dos Santos Jorge Artur Peçanha de Miranda Coelho |
| author_sort | João Marcelo de Almeida Gusmão Lyra |
| collection | DOAJ |
| description | Abstract Background Multifocal intraocular lenses (IOLs) are designed to reduce dependence on spectacles by providing multiple focal points. However, they are associated with photic phenomena such as halos and glare, and may reduce contrast sensitivity. The BIOS Trifocal is a single-piece acrylic diffractive IOL with a closed-loop haptic design, optimized for centration and stability. It features an aspheric, aberration-neutral surface and a precisely engineered diffraction grating for effective energy distribution across multiple distances. This study aims to evaluate the visual, clinical, and quality of life outcomes of the BIOS Trifocal IOL for treatment of cataract and presbyopia. Methods Participants who met the inclusion criteria underwent implantation of the BIOS Trifocal IOL and were assessed at 30 and 90 days post-surgery. The evaluations included measurements of patient-reported outcomes using the NEI-VFQ 25 at postoperative day 30 and uncorrected and corrected distance visual acuity and defocus curves at postoperative day 90. Additionally, intraoperative and postoperative complications were documented. Visual acuity assessments were performed under photopic conditions, with a range of defocus from + 1.5 D to -3.0 D. Results Significant improvements were observed in uncorrected distance visual acuity (UDVA), corrected distance visual acuity (CDVA), and near visual acuity (UNVA) at both 30 and 90 days post-surgery (p < 0.001). The defocus curve demonstrated functional vision from + 1.5 D to -3.0 D, supporting the lens’s efficacy for near, intermediate, and far distances. Quality of life, as assessed by the NEI-VFQ 25, showed marked improvement across all domains (p < 0.05), with no significant complications directly attributable to the IOL. Conclusions The BIOS Trifocal IOL presented satisfactory effectivity in the treatment of cataract and presbyopia, providing functional vision across near, intermediate and far distances and maintaining good patient satisfaction. Trial Registration This trial was registered at the ReBEC (Registro Brasileiro de Ensaios Clínicos – Brazilian Registry of Clinical Trials)database under the registration code RBR-772s6y at April 6th, 2020. |
| format | Article |
| id | doaj-art-7110491a6fec4c1f9c445a3af5c4d7fa |
| institution | Kabale University |
| issn | 1471-2415 |
| language | English |
| publishDate | 2025-02-01 |
| publisher | BMC |
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| series | BMC Ophthalmology |
| spelling | doaj-art-7110491a6fec4c1f9c445a3af5c4d7fa2025-02-09T12:26:15ZengBMCBMC Ophthalmology1471-24152025-02-012511910.1186/s12886-025-03878-3Visual, clinical and quality of life outcomes of a new multifocal IOL with optimized diffractive grating: a non-randomized clinical trialJoão Marcelo de Almeida Gusmão Lyra0Mariana Silva Gois de Almeida1Lucila de Albuquerque Barbosa Lira2Laís Oliveira dos Santos3Mateus Lins dos Santos4Jorge Artur Peçanha de Miranda Coelho5Fundação João Carlos LyraFundação João Carlos LyraFundação João Carlos LyraFundação João Carlos LyraHospital de Olhos de SergipeUniversidade Federal de AlagoasAbstract Background Multifocal intraocular lenses (IOLs) are designed to reduce dependence on spectacles by providing multiple focal points. However, they are associated with photic phenomena such as halos and glare, and may reduce contrast sensitivity. The BIOS Trifocal is a single-piece acrylic diffractive IOL with a closed-loop haptic design, optimized for centration and stability. It features an aspheric, aberration-neutral surface and a precisely engineered diffraction grating for effective energy distribution across multiple distances. This study aims to evaluate the visual, clinical, and quality of life outcomes of the BIOS Trifocal IOL for treatment of cataract and presbyopia. Methods Participants who met the inclusion criteria underwent implantation of the BIOS Trifocal IOL and were assessed at 30 and 90 days post-surgery. The evaluations included measurements of patient-reported outcomes using the NEI-VFQ 25 at postoperative day 30 and uncorrected and corrected distance visual acuity and defocus curves at postoperative day 90. Additionally, intraoperative and postoperative complications were documented. Visual acuity assessments were performed under photopic conditions, with a range of defocus from + 1.5 D to -3.0 D. Results Significant improvements were observed in uncorrected distance visual acuity (UDVA), corrected distance visual acuity (CDVA), and near visual acuity (UNVA) at both 30 and 90 days post-surgery (p < 0.001). The defocus curve demonstrated functional vision from + 1.5 D to -3.0 D, supporting the lens’s efficacy for near, intermediate, and far distances. Quality of life, as assessed by the NEI-VFQ 25, showed marked improvement across all domains (p < 0.05), with no significant complications directly attributable to the IOL. Conclusions The BIOS Trifocal IOL presented satisfactory effectivity in the treatment of cataract and presbyopia, providing functional vision across near, intermediate and far distances and maintaining good patient satisfaction. Trial Registration This trial was registered at the ReBEC (Registro Brasileiro de Ensaios Clínicos – Brazilian Registry of Clinical Trials)database under the registration code RBR-772s6y at April 6th, 2020.https://doi.org/10.1186/s12886-025-03878-3CataractTrifocal IOLsMultifocal IOLsPresbyopia correcting IOLsIntraocular lenses |
| spellingShingle | João Marcelo de Almeida Gusmão Lyra Mariana Silva Gois de Almeida Lucila de Albuquerque Barbosa Lira Laís Oliveira dos Santos Mateus Lins dos Santos Jorge Artur Peçanha de Miranda Coelho Visual, clinical and quality of life outcomes of a new multifocal IOL with optimized diffractive grating: a non-randomized clinical trial BMC Ophthalmology Cataract Trifocal IOLs Multifocal IOLs Presbyopia correcting IOLs Intraocular lenses |
| title | Visual, clinical and quality of life outcomes of a new multifocal IOL with optimized diffractive grating: a non-randomized clinical trial |
| title_full | Visual, clinical and quality of life outcomes of a new multifocal IOL with optimized diffractive grating: a non-randomized clinical trial |
| title_fullStr | Visual, clinical and quality of life outcomes of a new multifocal IOL with optimized diffractive grating: a non-randomized clinical trial |
| title_full_unstemmed | Visual, clinical and quality of life outcomes of a new multifocal IOL with optimized diffractive grating: a non-randomized clinical trial |
| title_short | Visual, clinical and quality of life outcomes of a new multifocal IOL with optimized diffractive grating: a non-randomized clinical trial |
| title_sort | visual clinical and quality of life outcomes of a new multifocal iol with optimized diffractive grating a non randomized clinical trial |
| topic | Cataract Trifocal IOLs Multifocal IOLs Presbyopia correcting IOLs Intraocular lenses |
| url | https://doi.org/10.1186/s12886-025-03878-3 |
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