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

• Sponsor: Democritus University of Thrace (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02431156
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Duration (Months): 3
• Patients Per Site Per Month: 13.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Presbyopia	Other: Assessment of visual capacity

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 Design

• Study Type: Observational
• Anticipated Enrollment: 40 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• 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 Start Date: Mar 1, 2015
• Anticipated Primary Completion Date: Jun 1, 2015
• Anticipated Study Completion Date: Jun 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
monovision Presbyopic patients that underwent mini-monovision correction with bilateral implantation of monofocal intraocular lenses. Their visual capacity in ADLs will be assessed.	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

Outcome Measures

Primary Outcome Measures

1. 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

1. 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

2. 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

3. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Eye Institute Of thrace	Alexandroupolis	Evros	Greece	68100

Sponsors and Collaborators

• Democritus University of Thrace

Investigators

• Principal Investigator: Georgios Labiris, MD, PhD, Assistant Professor

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Georgios Labiris, Assistant Professor, Democritus University of Thrace
• ClinicalTrials.gov Identifier: NCT02431156
• Other Study ID Numbers: PseudoPresbADL
• First Posted: Apr 30, 2015
• Last Update Posted: Apr 30, 2015
• Last Verified: Apr 1, 2015

• Keywords provided by Georgios Labiris, Assistant Professor, Democritus University of Thrace: presbyopia; monovision; activities of daily living,; pseudophakic
• Additional relevant MeSH terms: Presbyopia

Study Results

No Results Posted as of Apr 30, 2015