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OpenTrials
Completed

NCT Number: NCT03226561

Assessment of Near Vision Capacity in Different Light Conditions Following Bilateral Trifocal Intraocular Implantation

Patients who underwent presbyopic correction with bilateral trifocal intraocular lenses implantation are supposed to have sufficient uncorrected vision capacity for activities of daily living (ADLs) that require near vision acuity (NV), (ie. book reading). However, it is known that light intensity and temperature has a great impact on near vision capacity. Primary objective of this study is to identify the optimal task lighting conditions (in terms of light intensity and temperature) for ADLs that demand near vision acuity for a sample of patients who underwent presbyopic correction with bilateral trifocal intraocular lenses implantation

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Key information

Conditions

Presbyopia Eye Diseases Refractive Errors

Age range

50 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Democritus University of Thrace

Alexandroupoli, Evros, 68100, Greece

About this study

Patients who underwent presbyopic correction with bilateral trifocal intraocular lenses implantation are supposed to have sufficient uncorrected vision capacity for activities of daily living (ADLs) that require near vision acuity (NV), (ie. book reading). However, it is known that light intensity and temperature has a great impact on near vision capacity. Primary objective of this study is to identify the optimal task lighting conditions (in terms of light intensity and temperature) for ADLs that demand near vision acuity for a sample of patients who underwent presbyopic correction with bilateral trifocal intraocular lenses implantation. The following light intensities will be evaluated: 25, 50, and 75 foot candles. Moreover, the following light temperatures will be evaluated: 3000, 4000, and 6000 Kelvins.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Presbyopia

Exclusion criteria

Glaucoma Corneal pathology Fundus pathology Severe neurological/mental diseases that interfere with visual acuity

Treatment and study plan

Phaco / Panoptix

Procedure

Phacoemulsification with bilateral diffractive trifocal lens implantation

Primary outcomes

  1. uNVC (3000K)

    Time frame: 6 months

    Uncorrected Near Vision Capacity at 3000 Kelvins

  2. uNVC (4000K)

    Time frame: 6 months

    Uncorrected Near Vision Capacity at 4000 Kelvins

  3. uNVC (6000K)

    Time frame: 6 months

    Uncorrected Near Vision Capacity at 6000 Kelvins

  4. uNVC (25FC)

    Time frame: 6 months

    Uncorrected Near Vision Capacity at 25 Foot Candles

  5. uNVC (50FC)

    Time frame: 6 months

    Uncorrected Near Vision Capacity at 50 Foot Candles

  6. uNVC (75FC)

    Time frame: 6 months

    Uncorrected Near Vision Capacity at 75 Foot Candles

Sponsors and collaborators

Lead sponsor

Democritus University of Thrace

Other

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jul 24, 2017
Registry last updated
Jul 25, 2019

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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