CataractNCT01998698
Monovision vs Multifocal Lens Insertion in Cataract Patients
A study testing Phacoemulsification surgery in people with Cataract, run by Democritus University of Thrace at 1 site in Greece.
Trial summary
The investigators would like to assess whether monovision correction of multifocal lens insertion provides more satisfaction to cataract patients following an uncomplicated phacoemulsification surgery. Read more about this study
- Who is it for?
- Ages 60 to 75 years
- Conditions the study is for
- Cataract
- What is being tested?
- Phacoemulsification surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteGreece
- Study dates
- Mar 2013to Sep 2013
- Phase
- Interventional
- 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 60 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Bilateral senile cataract
Who cannot join
- Glaucoma
- Corneal pathology
- Fundus pathology
- Severe neurological/mental diseases that interfere with visual acuity
- Former intraocular operation
Trial locations and contacts
1 site in 1 country.
Greece1 site
University Hospital of Alexandroupolis
Alexandroupoli, Evros, 68100
About this study
Official title: Monovision Correction Versus Multifocal Lens Insertion Following Emulsification Cataract Surgery
The investigators would like to assess whether monovision correction of multifocal lens insertion provides more satisfaction to cataract patients following an uncomplicated phacoemulsification surgery.
- Conditions
- Cataract
- Being tested
- Phacoemulsification surgery
- Keywords
- cataract, phacoemulsification, monovision, multifocal lens
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phacoemulsification surgeryProcedure or surgery
Also called Alcon Infiniti Vision System platform, Visthesia, Carl Zeiss, Germany, Alcon Intraocular lens SN60WF
Phacoemulsification surgery with intraocular lens implantation and monovision correction
Phacoemulsification surgeryProcedure or surgery
Also called Alcon Infiniti Vision System platform, Visthesia, Carl Zeiss, Germany, Hoya Intraocular lens PY-60MV
Phacoemulsification surgery with multifocal intraocular lens implantation
| Study group | Role | What they receive |
|---|---|---|
| Monovision Group | Active comparator | Phacoemulsification surgery with intraocular lens implantation (monovision correction) Receives: Procedure: Phacoemulsification surgery |
| Multifocal Group | Active comparator | Phacoemulsification surgery with intraocular lens implantation (multifocal lens insertion) Receives: Procedure: Phacoemulsification surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
VF14 score
Measured: 6 months following operation
Secondary outcomes (2)
Distant Visual Acuity
Measured: 6 months following surgery
Near Vision visual acuity
Measured: 6 months following surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2013 (estimated)
- Study startMar 2013
- Primary completionSep 2013
- Study completionSep 2013
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 CataractStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
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
- NCT01998698
- Sponsor's protocol ID
- 192/19-11-2013
- Status last verified
- Jan 2017
- First submitted
- 19 Nov 2013
- Last updated
- 18 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Labiris G, Giarmoukakis A, Patsiamanidi M, Papadopoulos Z, Kozobolis VP. Mini-monovision versus multifocal intraocular lens implantation. J Cataract Refract Surg. 2015 Jan;41(1):53-7. doi: 10.1016/j.jcrs.2014.06.015. Epub 2014 Jun 21.
PubMed 24962144
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monovision Correction Versus Multifocal Lens Insertion Following Emulsification Cataract Surgery
- ClinicalTrials.gov ID
- NCT01998698
- Acronym / sponsor ID
- 192/19-11-2013
- Conditions
- Cataract
- Keywords
- cataract, phacoemulsification, monovision, multifocal lens
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Democritus University of ThraceUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 2 Dec 2013 (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.
The investigators would like to assess whether monovision correction of multifocal lens insertion provides more satisfaction to cataract patients following an uncomplicated phacoemulsification surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Monovision Group | Active comparator | Procedure: Phacoemulsification surgeryPhacoemulsification surgery with intraocular lens implantation (monovision correction) |
| Multifocal Group | Active comparator | Procedure: Phacoemulsification surgeryPhacoemulsification surgery with intraocular lens implantation (multifocal lens insertion) |
Who may qualify
- Ages
- 60 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Bilateral senile cataract
Key exclusion criteria (5 listed)
- Glaucoma
- Corneal pathology
- Fundus pathology
- Severe neurological/mental diseases that interfere with visual acuity
- Former intraocular operation
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 |
|---|---|---|
| Phacoemulsification surgeryAlso: Alcon Infiniti Vision System platform, Visthesia, Carl Zeiss, Germany, Alcon Intraocular lens SN60WFPhacoemulsification surgery with intraocular lens implantation and monovision correction | Procedure or surgery | Monovision Group |
| Phacoemulsification surgeryAlso: Alcon Infiniti Vision System platform, Visthesia, Carl Zeiss, Germany, Hoya Intraocular lens PY-60MVPhacoemulsification surgery with multifocal intraocular lens implantation | Procedure or surgery | Multifocal Group |
Primary outcome
VF14 score
Time frame: 6 months following operation
2 secondary outcomes
Distant Visual Acuity
Time frame: 6 months following surgery
Near Vision visual acuity
Time frame: 6 months following surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2017.
- Results publication: PubMed 24962144Labiris G, Giarmoukakis A, Patsiamanidi M, Papadopoulos Z, Kozobolis VP. Mini-monovision versus multifocal intraocular lens implantation. J Cataract Refract Surg. 2015 Jan;41(1):53-7. doi: 10.1016/j.jcrs.2014.06.015. Epub 2014 Jun 21.
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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?
A study testing Phacoemulsification surgery in people with Cataract, 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 5 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: finished, as of the sponsor's last update on 18 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VF14 score (time frame: 6 months following operation). 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 NCT01998698, 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 18 Jan 2017.