PresbyopiaNCT03021512
Functional Assessment of ADL in Patients Who Underwent Bifocal and Trifocal Presbyopic Correction
An observational study of Presbyopia, run by Democritus University of Thrace at 1 site in Greece.
Trial summary
Patients who underwent bilateral bifocal or trifocal lenses implantation 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 65 years
- Conditions the study is for
- Presbyopia
- What is being tested?
- Phaco with Restor and Phaco with Panoptix
- Type of treatment
- Surgery or procedure
- How many people
- 80 participants
- Where
- 1 siteGreece
- Study dates
- Jan 2017to Jan 2018
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Grade 1 Cataract Patients
Who may be able to join
- Presbyopic patients that underwent either bilateral bifocal or trifocal intraocular lenses implantation
Who cannot join
- Glaucoma, Corneal pathology, Fundus pathology, Mental or Neurological disorder
Trial locations and contacts
1 site in 1 country.
Greece1 site, 1 recruiting
- Recruiting
Democritus University of Thrace
Alexandroupoli, Evros, 68100
Georgios Labiris, MD, PhD, 00302551030990, labiris@usa.net
About this study
Official title: Retrospective Functional Assessment of Activities of Daily Living (ADL) in Patients Who Underwent Bilateral Implantation of Aspheric Bifocal Intraocular Lenses or Aspheric Trifocal Intraocular Lenses
Patients who underwent bilateral bifocal or trifocal lenses implantation 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 objective of the study is the comparison in a series of ADLs of two cohorts of patients (group 1: subjects with bilateral bifocal lenses implantation, group 2: subjects with bilateral trifocal lenses implantation)
- Conditions
- Presbyopia
- Being tested
- Phaco with Restor, Phaco with Panoptix
- Medical subject headings
- Presbyopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phaco with RestorProcedure or surgery
Phacoemulsification with bilateral bifocal intraocular lenses implantation
Phaco with PanoptixProcedure or surgery
Phacoemulsification with bilateral trifocal intraocular lenses implantation
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (BFG) | (Bifocal group). Subjects that underwent bifocal intraocular lenses implantation. (ie. Phaco with Restor intervention). Receives: Procedure: Phaco with Restor | |
| Group 2 (TFG) | (Trifocal group). Subjects that underwent trifocal intraocular lenses implantation. (ie. Phaco with Panoptix intervention). Receives: Procedure: Phaco with Panoptix |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Capacity (VC)
Assessment of Visual capacity (VC)
Measured: 1 year following surgery
Secondary outcomes (3)
Distant Visual Capacity (DVC)
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 surgery
Intermediate Visual Capacity (IVC)
Visual Capacity for activities that require intermediate vision (IVC). VC 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 surgery
Near Visual Capacity (NVC)
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 follwoing surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2017 (estimated)
- Study startJan 2017
- Primary completionJan 2018 (estimated)
- Study completionJan 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 80 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
- NCT03021512
- Sponsor's protocol ID
- 299/13-1-2017
- Status last verified
- Jan 2017
- First submitted
- 13 Jan 2017
- Last updated
- 16 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2017. 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 Bilateral Implantation of Aspheric Bifocal Intraocular Lenses or Aspheric Trifocal Intraocular Lenses
- ClinicalTrials.gov ID
- NCT03021512
- Acronym / sponsor ID
- 299/13-1-2017
- Conditions
- Presbyopia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Democritus University of ThraceUniversity, hospital or other
- Study start
- Jan 2017
- Primary completion
- Jan 2018 (estimated)
- Study completion
- Jan 2018 (estimated)
- First posted
- 16 Jan 2017 (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 bilateral bifocal or trifocal lenses implantation 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 objective of the study is the comparison in a series of ADLs of two cohorts of patients (group 1: subjects with bilateral bifocal lenses implantation, group 2: subjects with bilateral trifocal lenses implantation)
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 (BFG) | – | Procedure: Phaco with Restor(Bifocal group). Subjects that underwent bifocal intraocular lenses implantation. (ie. Phaco with Restor intervention). |
| Group 2 (TFG) | – | Procedure: Phaco with Panoptix(Trifocal group). Subjects that underwent trifocal intraocular lenses implantation. (ie. Phaco with Panoptix intervention). |
Who may qualify
- Ages
- 50 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Grade 1 Cataract Patients
Key inclusion criteria (1 listed)
- Presbyopic patients that underwent either bilateral bifocal or trifocal intraocular lenses implantation
Key exclusion criteria (1 listed)
- Glaucoma, Corneal pathology, Fundus pathology, Mental or Neurological disorder
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 |
|---|---|---|
| Phaco with RestorPhacoemulsification with bilateral bifocal intraocular lenses implantation | Procedure or surgery | Group 1 (BFG) |
| Phaco with PanoptixPhacoemulsification with bilateral trifocal intraocular lenses implantation | Procedure or surgery | Group 2 (TFG) |
Primary outcome
Visual Capacity (VC)
Time frame: 1 year following surgery
Assessment of Visual capacity (VC)
3 secondary outcomes
Distant Visual Capacity (DVC)
Time frame: 1 year following surgery
Intermediate Visual Capacity (IVC)
Time frame: 1 year following surgery
Near Visual Capacity (NVC)
Time frame: 1 year follwoing surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2017.
- Individual participant dataSharing planned: No
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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 1 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 16 Jan 2017. 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 Dimitrios Aggelonias (00302551039891, dimagelonias@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Capacity (VC) (time frame: 1 year following surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Jan 2017.