Assessment of Near Vision Capacity in Different Light Intensities

Presbyopia Clinical Trial

Official title:

Assessment of Near Vision Capacity in Different Light Intensities and Temperatures in Patients Who Underwent Pseudophakic Presbyopic Correction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03024073
• Other study ID #: 300/13-1/2017
• Status: Completed
• Start date: January 2017
• Est. completion date: June 2018

Study information

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

Clinical Trial Summary

Patients who underwent presbyopic correction with bilateral bifocal 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 oa patients who underwent presbyopic correction with bilateral bifocal intraocular lenses implantation

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: June 2018
• Est. primary completion date: April 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 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:
• BB-Phaco
Phacoemulsification with bilateral bifocal lenses implantation

Locations

Country	Name	City	State
Greece	Democritus University of Thrace	Alexandroupolis	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	Uncorrected Near Vision Acuity (UnVA)	Near Vision Acuity	6 months
Secondary	Near Vision Capacity (NVC)	NVC score will be measured by the performance score in the following ADLs: a) cellular phone directory entry search, b) reading of message in a cellular phone, c) reading a medical prescription, d) reading a public phonebook	6 months