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

• Conditions: Presbyopia

• Registration Number: NCT02431156
• Lead Sponsor: Democritus University of Thrace

Brief 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.

Detailed 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

Study Timeline

• Study Start: 2015-03
• Status Verified: 2015-04
• Study First Submitted: 2015-04-01
• Study First Submitted QC: 2015-04-29
• Last Update Submitted: 2015-04-29
• Study First Posted: 2015-04-30
• Last Update Posted: 2015-04-30
• Primary Completion: 2015-06
• Study Completion: 2015-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Assessment of Visual capacity (VC)	1 year following mini-monovision correction surgery	VC will be measured as the sum of DVC, IVC, and NVC

Secondary Outcome Measures

Name	Time	Method
Visual capacity for activities that require distant vision (DVC)	1 year following mini-monovision correction surgery	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
Visual capacity for activities that require intermediate vision (IVC)	1 year following mini-monovision correction surgery	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
Visual capacity for activities that require near vision (NVC)	1 year following mini-monovision correction surgery	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

Trial Locations

Locations (1)

Eye Institute Of thrace; 🇬🇷 Alexandroupolis, Evros, Greece