PresbyopiaNCT02431156
Functional Assessment of Activities of Daily Living (ADL) in Patients Who Underwent Mini-monovision Correction
An observational study of Presbyopia, run by Democritus University of Thrace at 1 site in Greece.
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. Read more about this study
- Who is it for?
- Ages 50 to 60 years
- Conditions the study is for
- Presbyopia
- What is being tested?
- Assessment of visual capacity
- How many people
- 40 participants
- Where
- 1 siteGreece
- Study dates
- Mar 2015to Jun 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Presbyopic patients that underwent mini-monovision correction with bilateral myopic defocus with monofocal intraocular lenses implantation
Who may be able to join
- Presbyopic patients that underwent mini-monovision correction with bilateral myopic defocus with monofocal intraocular lenses implantation
Who cannot join
- Glaucoma
- Corneal pathology
- Fundus pathology
- Severe neurological/mental diseases that interfere with visual acuity
Trial locations and contacts
1 site in 1 country.
Greece1 site, 1 recruiting
- Recruiting
Eye Institute Of thrace
Alexandroupoli, Evros, 68100
Aggelonias Dimitrios, 00302551030991, dimagelonias@yahoo.com
About this study
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
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.
Read the 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
- Conditions
- Presbyopia
- Being tested
- Assessment of visual capacity
- Keywords
- presbyopia, monovision, activities of daily living,, pseudophakic
- Medical subject headings
- Presbyopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment of visual capacityOther
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
| Study group | Role | What they receive |
|---|---|---|
| monovision | Presbyopic patients that underwent mini-monovision correction with bilateral implantation of monofocal intraocular lenses. Their visual capacity in ADLs will be assessed. Receives: Other: Assessment of visual capacity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of Visual capacity (VC)
VC will be measured as the sum of DVC, IVC, and NVC
Measured: 1 year following mini-monovision correction surgery
Secondary outcomes (3)
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
Measured: 1 year following mini-monovision correction surgery
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
Measured: 1 year following mini-monovision correction surgery
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
Measured: 1 year following mini-monovision correction surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2015 (estimated)
- Study startMar 2015
- Primary completionJun 2015 (estimated)
- Study completionJun 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PresbyopiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Democritus University of Thrace
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Georgios Labiris, Democritus University of Thrace
- Investigators
- Georgios Labiris, MD, PhD, Principal investigator, Assistant Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02431156
- Sponsor's protocol ID
- PseudoPresbADL
- Status last verified
- Apr 2015
- First submitted
- 1 Apr 2015
- Last updated
- 30 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 28116335
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02431156
- Acronym / sponsor ID
- PseudoPresbADL
- Conditions
- Presbyopia
- Keywords
- presbyopia, monovision, activities of daily living,, pseudophakic
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Democritus University of ThraceUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Jun 2015 (estimated)
- Study completion
- Jun 2015 (estimated)
- First posted
- 30 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| monovision | – | Other: Assessment of visual capacityPresbyopic patients that underwent mini-monovision correction with bilateral implantation of monofocal intraocular lenses. Their visual capacity in ADLs will be assessed. |
Who may qualify
- Ages
- 50 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Presbyopic patients that underwent mini-monovision correction with bilateral myopic defocus with monofocal intraocular lenses implantation
Key inclusion criteria (1 listed)
- Presbyopic patients that underwent mini-monovision correction with bilateral myopic defocus with monofocal intraocular lenses implantation
Key exclusion criteria (4 listed)
- Glaucoma
- Corneal pathology
- Fundus pathology
- Severe neurological/mental diseases that interfere with visual acuity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Assessment of visual capacityVisual 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 | Other | monovision |
Primary outcome
Assessment of Visual capacity (VC)
Time frame: 1 year following mini-monovision correction surgery
VC will be measured as the sum of DVC, IVC, and NVC
3 secondary outcomes
Visual capacity for activities that require distant vision (DVC)
Time frame: 1 year following mini-monovision correction surgery
Visual capacity for activities that require intermediate vision (IVC)
Time frame: 1 year following mini-monovision correction surgery
Visual capacity for activities that require near vision (NVC)
Time frame: 1 year following mini-monovision correction surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2015.
- Derived from this study: PubMed 28116335Labiris 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Georgios Labiris, MD, PhD principal investigator
Assistant Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Presbyopia, run by Democritus University of Thrace at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Georgios Labiris, MD, PhD (00302551039891, labiris@usa.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of Visual capacity (VC) (time frame: 1 year following mini-monovision correction surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02431156, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2015.