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OpenTrials
Completed

NCT Number: NCT04134507

Patient Satisfaction in Post-LASIK Patients With Presbyopia-Correcting IOLs vs. Post-Lasik Patients With Monofocal IOLs

Compare functional visual outcomes and patient satisfaction of post-LASIK patients having received presbyopia-correcting IOLs versus post-LASIK patients having received monofocal IOLs

Completed

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Key information

Conditions

Patient Satisfaction Behavior Health Behavior Treatment Adherence and Compliance

Sex eligibility

All sexes

Study type

Observational

Primary location

Bucci Laser Vision

Wilkes-Barre, Pennsylvania, 18702, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Post-LASIK
  • Post cataract surgery
  • Implantation of ZLB00, ZXR or ZXT, ZCB00, or AO60 intraocular lenses
  • Spherical values greater than ± 0.50 and/or cylinder magnitude greater than 0.75D

Exclusion criteria

  • Any vision-limiting problems (e.g., corneal, retinal, infection) which could potentially limit their post-operative visual potential
  • Any newly acquired ocular condition or pathology (e.g., ARMD, epiretinal membrane, chronic dry eye, irregular astigmatism, diabetic retinopathy)
  • Max sphere no greater than ± 0.50D and cylinder less than and/or equal to 0.75D

Treatment and study plan

Primary outcomes

  1. Patient Satisfaction: subjective questionnaire

    Time frame: Measured 3 months to 4 years after cataract surgery

    Subjective questionnaire explores the frequency and need for glasses for various visual functions at distance, intermediate, and near and overall satisfaction of visual function without glasses

Secondary outcomes

  1. Visual Acuity at Distance

    Time frame: Measured 3 months to 4 years after cataract surgery

    Uncorrected and best corrected visual acuities measured at distance

  2. Visual Acuity at Intermediate

    Time frame: Measured 3 months to 4 years after cataract surgery

    Uncorrected and best corrected visual acuities measured at intermediate

  3. Visual Acuity at Near

    Time frame: Measured 3 months to 4 years; after cataract surgery

    Uncorrected and best corrected visual acuities measured at near

Sponsors and collaborators

Lead sponsor

Bucci Laser Vision Institute

Other

Registry information

Official study title

Multivariate Regression Analysis of Patient Satisfaction in Post-LASIK Patients With Presbyopia-Correcting IOLs vs. Post-LASIK Patients With Monofocal IOLs

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Oct 22, 2019
Registry last updated
Dec 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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