CataractNCT02183831
Comparison of Clinical Outcomes After Cataract Surgery With and Without Capsular Tension Ring
An observational study of Cataract, run by Yonsei University.
Trial summary
This study was set up to identify clinical outcomes including a refractive shift or change in IOL calculation accuracy and optical quality after Ophtec® capsular tension ring in the eyes without zonular instability. Read more about this study
- Who is it for?
- Ages 40 to 79 years
- Conditions the study is for
- Cataract
- What is being tested?
- Insertion of the capsular tension ring
- Type of treatment
- Medical device
- How many people
- 52 participants
- Where
- No sites listed yet
- Study dates
- May 2014to Jun 2014
- 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 40 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The patients who were planned to undergo the cataract surgery in Department of Ophthalmology, Yonsei University College of Medicine
Who may be able to join
- age between 40 and 79 years
- no history of eye surgery or glaucoma
- a transparent central cornea
- pupil dilation at the preoperative examination of at least 6.0 mm
- absence of biomicroscopic signs of pseudoexfoliation
- normal fundus examination
Who cannot join
- presence of ocular disease that might affect the visual outcome (e.g., color vision disturbance, chronic uveitis)
- presence of ocular disease that might affect contrast sensitivity function (e.g., glaucoma, maculopathy, high myopia)
About this study
This study was set up to identify clinical outcomes including a refractive shift or change in IOL calculation accuracy and optical quality after Ophtec® capsular tension ring in the eyes without zonular instability.
- Conditions
- Cataract
- Being tested
- Insertion of the capsular tension ring
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insertion of the capsular tension ringDevice
Also called a pre-loaded CTR in single use injector was inserted just before IOL implantation during cataract surgery
| Study group | Role | What they receive |
|---|---|---|
| Capsular tension ring non insertion group | The patients who had same cataract surgery procedure without CTR insertion | |
| Capsular tension ring insertion group | The patients who underwent capsular tension ring insertion just before IOL implantation during cataract surgery Receives: Device: Insertion of the capsular tension ring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best corrected visual acuity
Visual acuity measurement using refractive error correction
Measured: 1 month after capsular tension ring and intraocular lens implantation (cataract surgery) using capsular tension ring
refractive error
Autokeratometry (KR-7100; Topcon, Tokyo, Japan) and manifested refraction were performed to examine refractive errors
Measured: 1 month after capsular tension ring and intraocular lens implantation (cataract surgery) using capsular tension ring
Anterior chamber depth
obtained with a Scheimpflug imaging system (Pentacam; OCULUS Optikgeräte GmbH, Wetzlar, Germany)
Measured: 3 months after capsular tension ring and intraocular lens implantation (cataract surgery) using capsular tension ring
Ocular aberrations
measured using the ray-tracing aberrometer (iTrace, Tracey Technologies, Houston, TX, USA) at a pupil size of 5 mm in mesopic conditions, without pharmacologic dilatation
Measured: 1month after capsular tension ring and intraocular lens implantation (cataract surgery) using capsular tension ring
Secondary outcomes (5)
constrast sensitivity
measured at five spatial frequencies (1.5, 3, 6, 12, and 18 Hz) using the Optec 6500 vision testing system
Measured: 3 months after capsular tension ring and intraocular lens implantation (cataract surgery) using capsular tension ring
posterior capsular opacity grades
graded after dilation of pupil over 6 mm, based on slit lamp examination findings
Measured: 3 months after capsular tension ring and intraocular lens implantation (cataract surgery) using capsular tension ring
Best corrected visual acuity
Visual acuity measurement using refractive error correction
Measured: 3 months after capsular tension ring and intraocular lens implantation (cataract surgery) using capsular tension ring
refractive error
Autokeratometry (KR-7100; Topcon, Tokyo, Japan) and manifested refraction were performed to examine refractive errors
Measured: 3 months after capsular tension ring and intraocular lens implantation (cataract surgery) using capsular tension ring
Ocular aberrations
measured using the ray-tracing aberrometer (iTrace, Tracey Technologies, Houston, TX, USA) at a pupil size of 5 mm in mesopic conditions, without pharmacologic dilatation
Measured: 3 months after capsular tension ring and intraocular lens implantation (cataract surgery) using capsular tension ring
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2014 (estimated)
- Study startMay 2014
- Primary completionJun 2014
- Study completionJun 2014
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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 52 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
- NCT02183831
- Sponsor's protocol ID
- 1-2014-0010
- Status last verified
- Jun 2014
- First submitted
- 23 Jun 2014
- Last updated
- 8 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Clinical Outcomes After Cataract Surgery With and Without Capsular Tension Ring
- ClinicalTrials.gov ID
- NCT02183831
- Acronym / sponsor ID
- 1-2014-0010
- Conditions
- Cataract
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 8 Jul 2014 (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 was set up to identify clinical outcomes including a refractive shift or change in IOL calculation accuracy and optical quality after Ophtec® capsular tension ring in the eyes without zonular instability.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Capsular tension ring non insertion group | – | –The patients who had same cataract surgery procedure without CTR insertion |
| Capsular tension ring insertion group | – | Device: Insertion of the capsular tension ringThe patients who underwent capsular tension ring insertion just before IOL implantation during cataract surgery |
Who may qualify
- Ages
- 40 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patients who were planned to undergo the cataract surgery in Department of Ophthalmology, Yonsei University College of Medicine
Key inclusion criteria (6 listed)
- age between 40 and 79 years
- no history of eye surgery or glaucoma
- a transparent central cornea
- pupil dilation at the preoperative examination of at least 6.0 mm
- absence of biomicroscopic signs of pseudoexfoliation
Key exclusion criteria (2 listed)
- presence of ocular disease that might affect the visual outcome (e.g., color vision disturbance, chronic uveitis)
- presence of ocular disease that might affect contrast sensitivity function (e.g., glaucoma, maculopathy, high myopia)
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 |
|---|---|---|
| Insertion of the capsular tension ringAlso: a pre-loaded CTR in single use injector was inserted just before IOL implantation during cataract surgery | Device | Capsular tension ring insertion group |
Primary outcome
Best corrected visual acuity
Time frame: 1 month after capsular tension ring and intraocular lens implantation (cataract surgery) using capsular tension ring
Visual acuity measurement using refractive error correction
refractive error
Time frame: 1 month after capsular tension ring and intraocular lens implantation (cataract surgery) using capsular tension ring
Autokeratometry (KR-7100; Topcon, Tokyo, Japan) and manifested refraction were performed to examine refractive errors
Anterior chamber depth
Time frame: 3 months after capsular tension ring and intraocular lens implantation (cataract surgery) using capsular tension ring
obtained with a Scheimpflug imaging system (Pentacam; OCULUS Optikgeräte GmbH, Wetzlar, Germany)
Ocular aberrations
Time frame: 1month after capsular tension ring and intraocular lens implantation (cataract surgery) using capsular tension ring
measured using the ray-tracing aberrometer (iTrace, Tracey Technologies, Houston, TX, USA) at a pupil size of 5 mm in mesopic conditions, without pharmacologic dilatation
5 secondary outcomes
constrast sensitivity
Time frame: 3 months after capsular tension ring and intraocular lens implantation (cataract surgery) using capsular tension ring
posterior capsular opacity grades
Time frame: 3 months after capsular tension ring and intraocular lens implantation (cataract surgery) using capsular tension ring
Best corrected visual acuity
Time frame: 3 months after capsular tension ring and intraocular lens implantation (cataract surgery) using capsular tension ring
refractive error
Time frame: 3 months after capsular tension ring and intraocular lens implantation (cataract surgery) using capsular tension ring
Ocular aberrations
Time frame: 3 months after capsular tension ring and intraocular lens implantation (cataract surgery) using capsular tension ring
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 8 Jul 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Cataract, run by Yonsei University.
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 6 inclusion and 2 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 8 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
Best corrected visual acuity (time frame: 1 month after capsular tension ring and intraocular lens implantation (cataract surgery) using capsular tension ring). The study lists 4 primary outcomes in all. 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 8 Jul 2014.