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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-55
SponsorZhongshan Ophthalmic Center, Sun Yat-sen University

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Laser Blended Vision LASIK

    Procedure/Surgery

    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

    Procedure/Surgery

    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.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Laser Blended Vision LASIKExperimental treatment 1 intervention
Group B: Traditional Monovision LASIKActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
6 months after surgery

Secondary outcomes

1

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.

Time frame
1 week, 1 month, 3 months, and 6 months after surgery
2

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.

Time frame
1 week, 1 month, 3 months, and 6 months after surgery
3

Refractive stability over time

Refractive stability will be assessed by changes in spherical equivalent during follow-up visits.

Time frame
Up to 6 months after surgery
4

Contrast sensitivity

Contrast sensitivity will be measured using a standardized contrast sensitivity testing system (CSV-1000, VectorVision, USA) at multiple spatial frequencies.

Time frame
1 week, 1 month, 3 months, and 6 months after surgery

Other outcomes

Sponsors and contacts

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