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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03021512
Other study ID # 299/13-1-2017
Secondary ID
Status Recruiting
Phase N/A
First received January 13, 2017
Last updated January 13, 2017
Start date January 2017
Est. completion date January 2018

Study information

Verified date January 2017
Source Democritus University of Thrace
Contact Dimitrios Aggelonias
Phone 00302551039891
Email dimagelonias@yahoo.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Patients who underwent bilateral bifocal or trifocal lenses implantation for presbyopia correction with monofocal intraocular lenses implantation are supposed to have sufficient uncorrected vision capacity for activities of daily living (ADLs) that require: a) distant vision (DV), (ie. driving), b) intermediate vision (IV), (ie. computer word processing), c) near vision (NV), (ie. book reading). Primary objective of the study is the comparison in a series of ADLs of two cohorts of patients (group 1: subjects with bilateral bifocal lenses implantation, group 2: subjects with bilateral trifocal lenses implantation)


Recruitment information / eligibility

Status Recruiting
Enrollment 80
Est. completion date January 2018
Est. primary completion date January 2018
Accepts healthy volunteers No
Gender All
Age group 50 Years to 65 Years
Eligibility Inclusion Criteria:

- Presbyopic patients that underwent either bilateral bifocal or trifocal intraocular lenses implantation

Exclusion Criteria:

- Glaucoma, Corneal pathology, Fundus pathology, Mental or Neurological disorder

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Phaco with Restor
Phacoemulsification with bilateral bifocal intraocular lenses implantation
Phaco with Panoptix
Phacoemulsification with bilateral trifocal intraocular lenses implantation

Locations

Country Name City State
Greece Democritus University of Thrace Alexandhroupolis 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 Visual Capacity (VC) Assessment of Visual capacity (VC) 1 year following surgery
Secondary Distant Visual Capacity (DVC) Visual capacity for activities that require distant vision (DVC). DVC score will be measured by the performance score in the following ADLs: a) walking specific pathway, 2) walking up stairs, 3) walking down stairs, 4) day-time driving simulation, 5) night-time driving simulation 1 year following surgery
Secondary Intermediate Visual Capacity (IVC) Visual Capacity for activities that require intermediate vision (IVC). VC score will be measured by the performance score in the following ADLs: a) reading ability of movie subtitles, b) reading ability of a predefined computer screen text, c) reading a supermarket badge 1 year following surgery
Secondary Near Visual Capacity (NVC) Visual Capacity for activities that require near vision (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 1 year follwoing surgery
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