Functional Assessment of Activities of Daily Living (ADL) in Patients Who Underwent Mini-monovision Correction

Presbyopia Clinical Trial

Official title:

Retrospective Functional Assessment of Activities of Daily Living (ADL) in Patients Who Underwent Mini-monovision Correction With Bilateral Implantation of Aspheric Monofocal Intraocular Lenses

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02431156
• Other study ID #: PseudoPresbADL
• Status: Recruiting
• Phase: N/A
• First received: April 1, 2015
• Last updated: April 29, 2015
• Start date: March 2015
• Est. completion date: June 2015

Study information

• Verified date: April 2015
• Source: Democritus University of Thrace
• Contact: Georgios Labiris, MD, PhD
• Phone: 00302551039891
• Email: labiris[@]usa.net
• Is FDA regulated: No
• Health authority: Greece: Ethics Committee
• Study type: Observational

Clinical Trial Summary

Patients who underwent mini-monovision (with bilateral myopic defocus, MM-BMD) surgery 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 objectives of the study are: 1) the development of a series of tasks in a research setting that will simulate common ADLs that require DV, IV, and NV. 2) the identification of potential correlations of the tasks in the research setting with demographic, clinical and other parameters of the study participants.

Description:

Patients who underwent mini-monovision (with bilateral myopic defocus, MM-BMD) surgery 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 objectives of the study are: 1) the development of a series of tasks in a research setting that will simulate common ADLs that require DV, IV, and NV. 2) the identification of potential correlations of the tasks in the research setting with demographic, clinical and other parameters of the study participants

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 60 Years

Eligibility

Inclusion Criteria:

• Presbyopic patients that underwent mini-monovision correction with bilateral myopic defocus with monofocal intraocular lenses implantation

Exclusion Criteria:

• Glaucoma

• Corneal pathology

• Fundus pathology

• Severe neurological/mental diseases that interfere with visual acuity

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Presbyopia

Intervention

Other:
• Assessment of visual capacity
Visual capacity (VC) is variable comprised by three sub-variables: a) (DVC) Visual capacity for activities requiring distant vision, b) (IVC) Visual capacity for activities requiring intermediate vision, and c) (NVC) Visual capacity for activities requiring near vision. VC will be measured in a scale from 1 to 100 as the sum of the DVC, IVC and NVC

Locations

Country	Name	City	State
Greece	Eye Institute 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	Assessment of Visual capacity (VC)	VC will be measured as the sum of DVC, IVC, and NVC	1 year following mini-monovision correction surgery	No
Secondary	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 mini-monovision correction surgery	No
Secondary	Visual capacity for activities that require intermediate vision (IVC)	IVC 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 mini-monovision correction surgery	No
Secondary	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 following mini-monovision correction surgery	No