Comparison of PRESBYOND Laser Blended Vision and Conventional Monovision LASIK in Individuals With Presbyopia: A Randomized Clinical Study

Обзор

The goal of this clinical trial is to learn if laser blended vision (LBV) works better than traditional monovision LASIK to correct presbyopia in adults aged 40 to 55 years. Presbyopia is an age-related condition that makes it hard to see things up close. The study will also evaluate the safety of both procedures. The main questions it aims to answer are: Does LBV improve distance, intermediate, and near vision at the same time after surgery? Is LBV as safe as traditional monovision LASIK? Researchers will compare laser blended vision to traditional monovision LASIK to see if LBV provides better overall vision after surgery. Participants will: Be randomly assigned to receive either laser blended vision or traditional monovision LASIK Have standard eye examinations before surgery Undergo LASIK surgery using the assigned method Return for follow-up visits at 1 week, 1 month, 3 months, and 6 months after surgery Complete vision tests and questionnaires about visual quality and satisfaction

Подробное описание

Presbyopia is an age-related condition that causes difficulty seeing at near distance and often leads to visual fatigue and dependence on reading glasses. Corneal refractive surgery has become an option for presbyopia correction. Traditional monovision LASIK corrects one eye for distance and the other eye for near vision, but some people may experience reduced depth perception or visual discomfort. Laser blended vision (LBV) is a modified LASIK technique designed to increase depth of focus and improve vision at multiple distances while maintaining binocular visual function. However, high-quality randomized clinical trials comparing LBV with traditional monovision LASIK are limited.

The purpose of this study is to compare the visual outcomes and safety of laser blended vision and traditional monovision LASIK in adults with presbyopia.

This study is a single-center, randomized, parallel-group clinical trial. About 100 participants aged 40 to 55 years who are suitable for LASIK surgery will be enrolled. Participants will be randomly assigned in a one-to-one ratio to receive either laser blended vision or traditional monovision LASIK.

All surgeries will be performed using standard LASIK procedures by experienced surgeons. Participants will undergo routine eye examinations before surgery and will be followed after surgery at scheduled visits, including 1 week, 1 month, 3 months, and 6 months.

The main evaluation will assess whether participants achieve good uncorrected distance, intermediate, and near vision at 6 months after surgery. Additional assessments will include refractive accuracy, visual quality, stereopsis, contrast sensitivity, patient-reported visual function, and safety outcomes.

Вмешательства

• Процедура Laser Blended Vision LASIK
  Laser blended vision LASIK is a refractive surgery technique for presbyopia correction. The dominant eye is corrected for distance vision, and the non-dominant eye is adjusted to mild myopia to improve near vision using a laser blended vision design.
• Процедура Traditional Monovision LASIK
  Monovision LASIK is a refractive surgery technique in which the dominant eye is corrected for distance vision and the non-dominant eye is corrected for near vision to improve presbyopia.

Первичные конечные точки

• Proportion of participants achieving target binocular visual acuity at multiple distances [Срок оценки: 6 months after surgery]

Вторичные конечные точки (10)

• Binocular uncorrected visual acuity [Срок оценки: 1 week, 1 month, 3 months, and 6 months after surgery]
• Refractive accuracy after surgery [Срок оценки: 1 week, 1 month, 3 months, and 6 months after surgery]
• Refractive stability over time [Срок оценки: Up to 6 months after surgery]
• Contrast sensitivity [Срок оценки: 1 week, 1 month, 3 months, and 6 months after surgery]
• Stereoacuity [Срок оценки: 1 week, 1 month, 3 months, and 6 months after surgery]
• NEI Visual Function Questionnaire-25 (NEI VFQ-25) [Срок оценки: 1 week, 1 month, 3 months, and 6 months after surgery]
• Quality of Vision (QoV) questionnaire [Срок оценки: 1 month, 3 months, and 6 months after surgery]
• Spectacle independence [Срок оценки: 1 month, 3 months, and 6 months after surgery]
• Visual safety outcomes [Срок оценки: 1 week, 1 month, 3 months, and 6 months after surgery]
• Postoperative complications [Срок оценки: From surgery to 6 months after surgery]

Критерии участия

Критерии включения

• Adults aged 40 to 55 years with presbyopia
• Suitable candidates for LASIK surgery based on clinical evaluation
• Stable refractive status for at least 1 year
• Best corrected distance visual acuity within normal range
• Willing and able to provide written informed consent
• Willing to comply with study visits and follow-up

Критерии исключения

• Previous ocular surgery
• Corneal disease or abnormal corneal condition that may affect safety
• Significant ocular disease affecting visual function
• Severe dry eye or other ocular surface disorders
• Systemic disease that may affect study participation
• Inability to tolerate monovision or anisometropia
• Any condition that the investigator considers unsuitable for the study

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Zhongshan Ophthalmic Center — Гуанчжоу

Публикации

• Waring GO 4th, Price FW Jr, Wirta D, McCabe C, Moshirfar M, Guo Q, Gore A, Liu H, Safyan E, Robinson MR. Safety and Efficacy of AGN-190584 in Individuals With Presbyopia: The GEMINI 1 Phase 3 Randomized Clinical Trial. JAMA Ophthalmol. 2022 Apr 1;140(4):363-371. doi: 10.1001/jamaophthalmol.2022.0059. PMID 35238902
• Hernandez-Lucena J, Alonso-Aliste F, Amian-Cordero J, Sanchez-Gonzalez JM. Outcomes of Corneal Compound Hyperopic Astigmatism With Presbyopia by Zeiss PRESBYOND Laser Blended Vision LASIK Using Default Custom Refractive Software Master Target Refractions for Reduced Anisometropia. J Refract Surg. 2024 Jul;40(7):e480-e489. doi: 10.3928/1081597X-20240506-02. Epub 2024 Jul 1. PMID 39007817
• Russo A, Reinstein DZ, Filini O, Archer TJ, Boldini A, Cardin G, Festa G, Morescalchi F, Salvalai C, Semeraro F. Visual and Refractive Outcomes Following Laser Blended Vision With Non-linear Aspheric Micro-anisometropia (PRESBYOND) in Myopic and Hyperopic Patients. J Refract Surg. 2022 May;38(5):288-297. doi: 10.3928/1081597X-20220323-01. Epub 2022 May 1. PMID 35536710
• Reinstein DZ, Ivory E, Chorley A, Archer TJ, Vida RS, Gupta R, Lewis T, Carp GI, Fonseca A, Parbhoo M. PRESBYOND Laser Blended Vision LASIK in Commercial and Military Pilots Requiring Class 1 Medical Certification. J Refract Surg. 2023 Jan;39(1):6-14. doi: 10.3928/1081597X-20221129-02. Epub 2023 Jan 1. PMID 36630432
• Ganesh S, Sriganesh SS. Laser refractive correction of presbyopia. Indian J Ophthalmol. 2024 Sep 1;72(9):1236-1243. doi: 10.4103/IJO.IJO_3074_23. Epub 2024 Aug 23. PMID 39185826
• Van Heerden A, Bigirimana D. Visual and Refractive Outcomes After Laser Blended Vision (PRESBYOND) in Patients With Myopia and Hyperopia. J Refract Surg. 2025 Oct;41(10):e1089-e1097. doi: 10.3928/1081597X-20250805-04. Epub 2025 Oct 1. PMID 41065739

Идентификаторы

NCT: NCT07512089 · IIT2025191 · 2026KYPJ018

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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