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

Not Applicable

Completed

• Conditions: Presbyopia

• Registration Number: NCT03226561
• Lead Sponsor: Democritus University of Thrace

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.

Study Timeline

• Study Start: 2017-07-01
• Study First Submitted: 2017-07-20
• Study First Submitted QC: 2017-07-20
• Study First Posted: 2017-07-24
• Primary Completion: 2018-04-01
• Study Completion: 2018-06-01
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-24
• Last Update Posted: 2019-07-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Presbyopia

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
uNVC (25FC)	6 months	Uncorrected Near Vision Capacity at 25 Foot Candles
uNVC (4000K)	6 months	Uncorrected Near Vision Capacity at 4000 Kelvins
uNVC (50FC)	6 months	Uncorrected Near Vision Capacity at 50 Foot Candles
uNVC (6000K)	6 months	Uncorrected Near Vision Capacity at 6000 Kelvins
uNVC (75FC)	6 months	Uncorrected Near Vision Capacity at 75 Foot Candles
uNVC (3000K)	6 months	Uncorrected Near Vision Capacity at 3000 Kelvins

Trial Locations

Locations (1)

Democritus University of Thrace; 🇬🇷 Alexandroúpoli, Evros, Greece