About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Laser Blended Vision LASIK
Procedure/SurgeryLaser 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.
Traditional Monovision LASIK
Procedure/SurgeryMonovision 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.
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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.
Refractive accuracy after surgery
Refractive accuracy will be evaluated using the difference between achieved and target refraction and the proportion of eyes within predefined refractive ranges.
Refractive stability over time
Refractive stability will be assessed by changes in spherical equivalent during follow-up visits.
Contrast sensitivity
Contrast sensitivity will be measured using a standardized contrast sensitivity testing system (CSV-1000, VectorVision, USA) at multiple spatial frequencies.
Sponsors and contacts
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