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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

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.

Study summary

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

Primary outcome measure(s)

• Proportion of participants achieving target binocular visual acuity at multiple distances — 6 months after surgery
  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.

Trial sites (1)

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