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| ID | Type | Description | Link |
|---|---|---|---|
| 2026KYPJ018 | Other Identifier | Ethics committee of the Zhongshan Ophthalmic Center, Sun Yat-sen University |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Laser Blended Vision LASIK | Experimental | Participants will undergo laser blended vision LASIK. The dominant eye will be corrected for distance vision, and the non-dominant eye will be targeted for mild myopia to improve near vision using a laser blended vision design. |
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| Traditional Monovision LASIK | Active Comparator | Participants will receive standard monovision LASIK for presbyopia correction, with the dominant eye corrected for distance and the non-dominant eye targeted for mild myopia to improve near vision. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laser Blended Vision LASIK | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants achieving target binocular visual acuity at multiple distances | Proportion of participants who achieve binocular uncorrected distance visual acuity (UDVA), uncorrected intermediate visual acuity (UIVA), and uncorrected near visual acuity (UNVA) of 0.8 (logMAR 0.10) or better. | 6 months after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Binocular uncorrected visual acuity | Binocular uncorrected distance visual acuity (UDVA), uncorrected intermediate visual acuity (UIVA), and uncorrected near visual acuity (UNVA) will be measured at scheduled follow-up visits. | 1 week, 1 month, 3 months, and 6 months after surgery |
| Refractive accuracy after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongshan Ophthalmic Center | Recruiting | Guangzhou | Guangdong | 510060 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35238902 | Background | 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. | |
| 39007817 | Background |
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| Traditional Monovision LASIK | Procedure | 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. |
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Refractive accuracy will be evaluated using the difference between achieved and target refraction and the proportion of eyes within predefined refractive ranges. |
| 1 week, 1 month, 3 months, and 6 months after surgery |
| Refractive stability over time | Refractive stability will be assessed by changes in spherical equivalent during follow-up visits. | Up to 6 months after surgery |
| Contrast sensitivity | Contrast sensitivity will be measured using a standardized contrast sensitivity testing system (CSV-1000, VectorVision, USA) at multiple spatial frequencies. | 1 week, 1 month, 3 months, and 6 months after surgery |
| Stereoacuity | Stereoacuity will be measured using a standardized stereopsis test (Randot Stereo Test) at near distance to evaluate binocular visual function. | 1 week, 1 month, 3 months, and 6 months after surgery |
| NEI Visual Function Questionnaire-25 (NEI VFQ-25) | Vision-related quality of life will be assessed using the National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25). The questionnaire includes multiple domains related to visual function and daily activities. Scores range from 0 to 100, with higher scores indicating better visual function. | 1 week, 1 month, 3 months, and 6 months after surgery |
| Quality of Vision (QoV) questionnaire | Visual symptoms will be assessed using the Quality of Vision (QoV) questionnaire, which evaluates the frequency, severity, and bothersome nature of visual disturbances such as glare, halos, starbursts, blur, and visual distortion. Responses are recorded on ordinal scales, and higher scores indicate worse visual quality. | 1 month, 3 months, and 6 months after surgery |
| Spectacle independence | Spectacle independence will be assessed using a structured questionnaire evaluating the need for glasses or contact lenses for distance, intermediate, and near vision, as well as the frequency of use during daily activities. Higher levels of independence indicate better functional visual outcomes. | 1 month, 3 months, and 6 months after surgery |
| Visual safety outcomes | Visual safety will be evaluated by changes in corrected distance visual acuity, including loss of one or more lines, loss of two or more lines, and calculation of the safety index. | 1 week, 1 month, 3 months, and 6 months after surgery |
| Postoperative complications | Postoperative complications and adverse events will be recorded during follow-up, including corneal complications, inflammatory or infectious events and the need for additional treatment. | From surgery to 6 months after surgery |
| 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. |
| 35536710 | Background | 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. |
| 36630432 | Background | 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. |
| 39185826 | Background | 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. |
| 41065739 | Background | 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. |
| ID | Term |
|---|---|
| D011305 | Presbyopia |
| D012030 | Refractive Errors |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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