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

Presbyopia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03226561
• Other study ID #: 334/20-7-2017
• Status: Completed
• Phase: N/A
• Start date: July 1, 2017
• Est. completion date: June 1, 2018

Study information

• Verified date: July 2019
• Source: Democritus University of Thrace
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: June 1, 2018
• Est. primary completion date: April 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 65 Years

Eligibility

Inclusion Criteria:

Presbyopia

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Myopia
• Presbyopia

Intervention

Procedure:
• Phaco / Panoptix
Phacoemulsification with bilateral diffractive trifocal lens implantation

Locations

Country	Name	City	State
Greece	Democritus University of Thrace	Alexandroúpoli	Evros

Sponsors (1)

Lead Sponsor	Collaborator
Democritus University of Thrace

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	uNVC (3000K)	Uncorrected Near Vision Capacity at 3000 Kelvins	6 months
Primary	uNVC (4000K)	Uncorrected Near Vision Capacity at 4000 Kelvins	6 months
Primary	uNVC (6000K)	Uncorrected Near Vision Capacity at 6000 Kelvins	6 months
Primary	uNVC (25FC)	Uncorrected Near Vision Capacity at 25 Foot Candles	6 months
Primary	uNVC (50FC)	Uncorrected Near Vision Capacity at 50 Foot Candles	6 months
Primary	uNVC (75FC)	Uncorrected Near Vision Capacity at 75 Foot Candles	6 months