CataractNCT02424162
Comparative Study of Two Multifocal Intraocular Lens With Different Add Power
A study testing +2.75 diopters multifocal intraocular lens and +3.25 diopters multifocal intraocular lens in people with Cataract, run by Yonsei University at 1 site in South Korea.
Trial summary
This study will compare cataract patients with implantation of diffractive multifocal IOL with an additional power of +2.75 diopters (Group 1) and with +3.25 diopters (Group 2). Evaluations will be performed 1 and 3 months following cataract surgery, including measurement of uncorrected distance visual acuity (UDVA)… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cataract
- What is being tested?
- +2.75 diopters multifocal intraocular lens and +3.25 diopters multifocal intraocular lens
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteSouth Korea
- Study dates
- 11 Nov 2014to 3 Nov 2015
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age >= 18
- cataract patients with lens opacities classification higher than grade III
- patients who desire to be spectacle indepence for distance and near vision
Who cannot join
- previous ocular surgery or trauma
- presence of corneal opacities
- fundus abnormalities
- glaucoma
- uveitis
- amblyopia
- systemic disease
- posterior capsule rupture during cataract surgery
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Institute of Vision Research, Department of Ophthalmology, Yonsei University College of Medicine
Seoul, 102-752
About this study
This study will compare cataract patients with implantation of diffractive multifocal IOL with an additional power of +2.75 diopters (Group 1) and with +3.25 diopters (Group 2). Evaluations will be performed 1 and 3 months following cataract surgery, including measurement of uncorrected distance visual acuity (UDVA), refractive error (manifest refraction [MR]), and uncorrected near visual acuity (UNVA) at 33, 40, and 50 cm. At 3 months, internal aberrations and contrast sensitivity will be evaluated and subjects will complete a questionnaire on outcomes satisfaction, visual symptoms, and spectacle use.
- Conditions
- Cataract
- Being tested
- +2.75 diopters multifocal intraocular lens, +3.25 diopters multifocal intraocular lens
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
+2.75 diopters multifocal intraocular lensDevice
+3.25 diopters multifocal intraocular lensDevice
| Study group | Role | What they receive |
|---|---|---|
| 2.75 group | Experimental | Patients with 2.75 diopters multifocal intraocular lens Receives: Device: +2.75 diopters multifocal intraocular lens |
| 3.25 group | Active comparator | Patients with +3.25 diopters multifocal intraocular lens Receives: Device: +3.25 diopters multifocal intraocular lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Acuity
Uncorrected distance visual acuity and uncorrected near visual acuity
Measured: 3 months
Secondary outcomes (2)
Contrast sensitivity measured by the Functional Acuity Contrast Test (FACT) of the Optec 6500 view-in test system
Internal aberrations measured by the ray-tracing aberrometer and contrast sensitivity measured by the Functional Acuity Contrast Test (FACT) of the Optec 6500 view-in test system
Measured: 3 months
internal aberration measured by the ray-tracing aberrometer
Internal aberrations measured by the ray-tracing aberrometer and contrast sensitivity measured by the Functional Acuity Contrast Test (FACT) of the Optec 6500 view-in test system
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2015 (estimated)
- Study start11 Nov 2014
- Primary completion3 Nov 2015
- Study completion3 Nov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02424162
- Sponsor's protocol ID
- 4-2014-0837
- Status last verified
- Feb 2019
- First submitted
- 17 Apr 2015
- Last updated
- 18 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Two Multifocal Intraocular Lens With Different Add Power
- ClinicalTrials.gov ID
- NCT02424162
- Acronym / sponsor ID
- 4-2014-0837
- Conditions
- Cataract
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 11 Nov 2014
- Primary completion
- 3 Nov 2015 (actual)
- Study completion
- 3 Nov 2015 (actual)
- First posted
- 22 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.
This study will compare cataract patients with implantation of diffractive multifocal IOL with an additional power of +2.75 diopters (Group 1) and with +3.25 diopters (Group 2). Evaluations will be performed 1 and 3 months following cataract surgery, including measurement of uncorrected distance visual acuity (UDVA), refractive error (manifest refraction [MR]), and uncorrected near visual acuity (UNVA) at 33, 40, and 50 cm. At 3 months, internal aberrations and contrast sensitivity will be evaluated and subjects will complete a questionnaire on outcomes satisfaction, visual symptoms, and spectacle use.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2.75 group | Experimental | Device: +2.75 diopters multifocal intraocular lensPatients with 2.75 diopters multifocal intraocular lens |
| 3.25 group | Active comparator | Device: +3.25 diopters multifocal intraocular lensPatients with +3.25 diopters multifocal intraocular lens |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age >= 18
- cataract patients with lens opacities classification higher than grade III
- patients who desire to be spectacle indepence for distance and near vision
Key exclusion criteria (8 listed)
- previous ocular surgery or trauma
- presence of corneal opacities
- fundus abnormalities
- glaucoma
- uveitis
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 |
|---|---|---|
| +2.75 diopters multifocal intraocular lens | Device | 2.75 group |
| +3.25 diopters multifocal intraocular lens | Device | 3.25 group |
Primary outcome
Visual Acuity
Time frame: 3 months
Uncorrected distance visual acuity and uncorrected near visual acuity
2 secondary outcomes
Contrast sensitivity measured by the Functional Acuity Contrast Test (FACT) of the Optec 6500 view-in test system
Time frame: 3 months
internal aberration measured by the ray-tracing aberrometer
Time frame: 3 months
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 Feb 2019.
Related trials for Cataract
RecruitingObservational study
Capella Scientia Development Study
Cataract
Recruiting
Clareon TruPlus Study
Aphakia, Astigmatism
RecruitingObservational study
Anterior Segment Anatomy Assessed by Swept-Source OCT in Ocular Surgery Patients
Cataract, Primary Angle-Closure Glaucoma
Active, not recruitingObservational study
Age-Related Eye Disease Study (AREDS) Follow-Up
Age-Related Macular Degeneration, Cataract
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing +2.75 diopters multifocal intraocular lens and +3.25 diopters multifocal intraocular lens in people with Cataract, run by Yonsei University at 1 site in South Korea.
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 3 inclusion and 8 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 Feb 2019. 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 South Korea. 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?
Visual Acuity (time frame: 3 months). 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 18 Feb 2019.