NCT02431156

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2015

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 1, 2015

Completed
29 days until next milestone

First Posted

Study publicly available on registry

April 30, 2015

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

April 30, 2015

Status Verified

April 1, 2015

Enrollment Period

3 months

First QC Date

April 1, 2015

Last Update Submit

April 29, 2015

Conditions

Keywords

presbyopiamonovisionactivities of daily living,pseudophakic

Outcome Measures

Primary Outcomes (1)

  • Assessment of Visual capacity (VC)

    VC will be measured as the sum of DVC, IVC, and NVC

    1 year following mini-monovision correction surgery

Secondary Outcomes (3)

  • Visual capacity for activities that require distant vision (DVC)

    1 year following mini-monovision correction surgery

  • Visual capacity for activities that require intermediate vision (IVC)

    1 year following mini-monovision correction surgery

  • Visual capacity for activities that require near vision (NVC)

    1 year following mini-monovision correction surgery

Study Arms (1)

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

Interventions

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

monovision

Eligibility Criteria

Age50 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • Glaucoma
  • Corneal pathology
  • Fundus pathology
  • Severe neurological/mental diseases that interfere with visual acuity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eye Institute Of thrace

Alexandroupoli, Evros, 68100, Greece

RECRUITING

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Presbyopia

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Study Officials

  • Georgios Labiris, MD, PhD

    Assistant Professor

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Georgios Labiris, MD, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 1, 2015

First Posted

April 30, 2015

Study Start

March 1, 2015

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

April 30, 2015

Record last verified: 2015-04

Locations