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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03226561
Enrollment
50
Registered
2017-07-24
Start date
2017-07-01
Completion date
2018-06-01
Last updated
2019-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Presbyopia

Brief summary

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

Detailed description

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.

Interventions

PROCEDUREPhaco / Panoptix

Phacoemulsification with bilateral diffractive trifocal lens implantation

Sponsors

Democritus University of Thrace
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
50 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

Presbyopia

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
uNVC (6000K)6 monthsUncorrected Near Vision Capacity at 6000 Kelvins
uNVC (3000K)6 monthsUncorrected Near Vision Capacity at 3000 Kelvins
uNVC (4000K)6 monthsUncorrected Near Vision Capacity at 4000 Kelvins
uNVC (25FC)6 monthsUncorrected Near Vision Capacity at 25 Foot Candles
uNVC (50FC)6 monthsUncorrected Near Vision Capacity at 50 Foot Candles
uNVC (75FC)6 monthsUncorrected Near Vision Capacity at 75 Foot Candles

Countries

Greece

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026