Clinical trial NCT02431156: Functional Assessment of Activities of Daily Living (ADL) in Patients Who Underwent Mini-monovision Correction
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Presbyopia
Keywords: presbyopia
monovision
activities of daily living,
pseudophakic
Lead sponsor: Democritus University of Thrace
Sponsor class: OTHER
First posted: 2015-04-30
Enrollment: 40
Sex: ALL
Minimum age (years): 50
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Presbyopic patients that underwent mini-monovision correction with bilateral myopic defocus with monofocal intraocular lenses implantation

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

Eligibility criteria: 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

Primary outcomes:
measure: Assessment of Visual capacity (VC)
timeFrame: 1 year following mini-monovision correction surgery
Secondary outcomes:
measure: Visual capacity for activities that require distant vision (DVC)
timeFrame: 1 year following mini-monovision correction surgery
measure: Visual capacity for activities that require intermediate vision (IVC)
timeFrame: 1 year following mini-monovision correction surgery
measure: Visual capacity for activities that require near vision (NVC)
timeFrame: 1 year following mini-monovision correction surgery
Other outcomes:
Locations:
city: Alexandroupolis
country: Greece
facility: Eye Institute Of thrace
state: Evros
Study officials:
affiliation: Assistant Professor
name: Georgios Labiris, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Labiris G, Ntonti P, Patsiamanidi M, Sideroudi H, Georgantzoglou K, Kozobolis VP. Evaluation of activities of daily living following pseudophakic presbyopic correction. Eye Vis (Lond). 2017 Jan 19;4:2. doi: 10.1186/s40662-016-0067-1. eCollection 2017.