Cataract, Age-RelatedNCT03674840
Comparison of Optical Quality With Different Placement of Refractive Multifocal Intraocular Lens
A study testing angle kappa based SBL-3 implantation and 0 to 180 degree SBL-3 implantation in people with Cataract, Age-Related, run by Peking University Third Hospital at 1 site in China.
Trial summary
The study aims to compare postoperative optical quality between two different implanting position of a rotationally asymmetric MIOL [SBL-3 Lenstec; +3.00 diopters (D)], angle kappa based implantation and 0 to 180 degree implantation, in order to find out the optimal implantation position for SBL-3. Read more about this study
- Who is it for?
- Ages 54 to 81 years
- Conditions the study is for
- Cataract, Age-Related
- What is being tested?
- angle kappa based SBL-3 implantation and 0 to 180 degree SBL-3 implantation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 12 Jun 2017to 1 Apr 2019
- 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 54 to 81 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age related cataract
- underwent bilateral cataract surgery and SBL-3 implantation
- corneal astigmatism <1.5D
Who cannot join
- patients with active ocular inflammation
- neuro-ophthalmic disease and macular disease
- previous corneal or intraocular surgery, corneal opacities or disease
- patients had surgical complications, pupillary trauma, inability to place the lens in the capsular bag
- IOL tilt or decentration deviated from intraoperative positioning
- difficulties with examinations and follow-up
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
About this study
The study aims to compare postoperative optical quality between two different implanting position of a rotationally asymmetric MIOL [SBL-3 Lenstec; +3.00 diopters (D)], angle kappa based implantation and 0 to 180 degree implantation, in order to find out the optimal implantation position for SBL-3.
Read the detailed description
SBL-3 has been proved to provide patients with good near, intermediate and distant visual acuity, but there is not much study on the impact of SBL-3 position on postoperative visual acuity.The regional refractive design of SBL-3 means it could be affected by pupil center shift (described by angle kappa: the difference between visual axis and pupil axis), the investigators assume that maintaining the ideal ratio of distant and near segment(50% vs 42%) in the pupil center could yield both good distant and near postoperative visual acuity postoperatively. Therefore, the investigators designed the implantation by placing the IOL based on angle kappa to make sure the ratio of distant and near segment exposure in the pupil center close to 50:42. In this study, the investigators assessed the optical quality in patients with SBL-3 implantation based on angle kappa and 0 to 180 degree to provide surgeons with information for choosing appropriate implantation position for optimum postoperative satisfaction of SBL-3.
- Conditions
- Cataract, Age-Related
- Being tested
- angle kappa based SBL-3 implantation, 0 to 180 degree SBL-3 implantation
- Keywords
- Multifocal Intraocular Lenses, visual acuity, kappa angle
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
angle kappa based SBL-3 implantationProcedure or surgery
SBL-3 implantation based on kappa angle guided by Callisto Eye System(Carl Zeiss Meditec, Germany) intraoperatively.
0 to 180 degree SBL-3 implantationProcedure or surgery
SBL-3 implantation in the direction of 0 to 180 degree guided by Callisto Eye System(Carl Zeiss Meditec, Germany) intraoperatively.
| Study group | Role | What they receive |
|---|---|---|
| control group | Other | Subjects in this group will go through a cataract surgery with SBL-3 implantation in the direction of 0 to 180 degree guided by Callisto Eye System(Carl Zeiss Meditec, Germany) intraoperatively. Receives: Procedure: 0 to 180 degree SBL-3 implantation |
| design group | Experimental | Subjects in this group will go through a cataract surgery with SBL-3 implantation based on kappa angle(described by Pentacam HR preoperatively) guided by Callisto Eye System(Carl Zeiss Meditec, Germany) intraoperatively. Receives: Procedure: angle kappa based SBL-3 implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Uncorrected visual acuity
Comparison of uncorrected distance visual acuity (UCVA), intermediate visual acuity, near visual acuity were measured at 5m, 80cm and 33cm respectively. All visual acuity measurements were conducted under photopic conditions (85 cd/m2) and at 100% contrast in design group and control group.
Measured: 3 months postoperatively
Secondary outcomes (3)
Optical quality
An OPD scan III aberrometer (NIDEK Co. Ltd., Gamagori, Japan) was used to evaluate postoperative mesopic and photopic pupil diameters and the quality of vision in each subject. Visual acuity was evaluated by MTF(modulation transfer function), SR(strehl ratio), intraocular total aberration, high order aberration, spherical aberration, coma aberration, trefoil aberration under 4mm pupil diameter.
Measured: 3 months postoperatively
Contrast sensitivity
Contrast sensitivity measures were conducted uniocularly, under photopic, mesopic (5 cd/m2), photopic with glare and mesopic with glare conditions, with the OPTEC 6500 contrast sensitivity test (Stereo Optical, USA). Contrast sensitivity was evaluated at five spatial frequencies (1.5, 3, 6, 12, and 18 cycles per degree [cpd]). Patients were allowed 5 minutes to adapt to each illumination level before testing.
Measured: 3 months postoperatively
Defocus curve
Monocular defocus curves were obtained in all patients, positioned at 5m under photopic (>85 cd/m 2 ) condition to measure the visual acuity with each defocus lens, representing the consecutive visual function of each eye. Negative lenses were added in 0.50 D steps and the visual acuity was recorded for each type of defocus level. The procedure was then repeated but with positive lenses. The range of defocus evaluated was from -4.00D to +2.00D.
Measured: 3 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2018
- Study start12 Jun 2017
- Primary completion1 Feb 2019
- Study completion1 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cataract, Age-RelatedStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment. For each patient one eye was randomly selected as design group and receive a SBL-3 implantation based on angle kappa, while the other eye was included in control group and receive a SBL-3implantation of 0 to 180 degree
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hong Qi, Peking University Third Hospital
- Investigators
- Hong Qi, Study director, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03674840
- Sponsor's protocol ID
- 20180906
- Status last verified
- Aug 2022
- First submitted
- 13 Sep 2018
- Last updated
- 5 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Optical Quality With Different Placement of Refractive Multifocal Intraocular Lens
- ClinicalTrials.gov ID
- NCT03674840
- Acronym / sponsor ID
- 20180906
- Conditions
- Cataract, Age-Related
- Keywords
- Multifocal Intraocular Lenses, visual acuity, kappa angle
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 12 Jun 2017 (actual)
- Primary completion
- 1 Feb 2019 (actual)
- Study completion
- 1 Apr 2019 (actual)
- First posted
- 18 Sep 2018 (actual)
- 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 study aims to compare postoperative optical quality between two different implanting position of a rotationally asymmetric MIOL [SBL-3 Lenstec; +3.00 diopters (D)], angle kappa based implantation and 0 to 180 degree implantation, in order to find out the optimal implantation position for SBL-3.
Detailed description
SBL-3 has been proved to provide patients with good near, intermediate and distant visual acuity, but there is not much study on the impact of SBL-3 position on postoperative visual acuity.The regional refractive design of SBL-3 means it could be affected by pupil center shift (described by angle kappa: the difference between visual axis and pupil axis), the investigators assume that maintaining the ideal ratio of distant and near segment(50% vs 42%) in the pupil center could yield both good distant and near postoperative visual acuity postoperatively. Therefore, the investigators designed the implantation by placing the IOL based on angle kappa to make sure the ratio of distant and near segment exposure in the pupil center close to 50:42. In this study, the investigators assessed the optical quality in patients with SBL-3 implantation based on angle kappa and 0 to 180 degree to provide surgeons with information for choosing appropriate implantation position for optimum postoperative satisfaction of SBL-3.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Parallel Assignment. For each patient one eye was randomly selected as design group and receive a SBL-3 implantation based on angle kappa, while the other eye was included in control group and receive a SBL-3implantation of 0 to 180 degree
| Arm | Type | Receives |
|---|---|---|
| control group | Other | Procedure: 0 to 180 degree SBL-3 implantationSubjects in this group will go through a cataract surgery with SBL-3 implantation in the direction of 0 to 180 degree guided by Callisto Eye System(Carl Zeiss Meditec, Germany) intraoperatively. |
| design group | Experimental | Procedure: angle kappa based SBL-3 implantationSubjects in this group will go through a cataract surgery with SBL-3 implantation based on kappa angle(described by Pentacam HR preoperatively) guided by Callisto Eye System(Carl Zeiss Meditec, Germany) intraoperatively. |
Who may qualify
- Ages
- 54 to 81 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age related cataract
- underwent bilateral cataract surgery and SBL-3 implantation
- corneal astigmatism <1.5D
Key exclusion criteria (6 listed)
- patients with active ocular inflammation
- neuro-ophthalmic disease and macular disease
- previous corneal or intraocular surgery, corneal opacities or disease
- patients had surgical complications, pupillary trauma, inability to place the lens in the capsular bag
- IOL tilt or decentration deviated from intraoperative positioning
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 |
|---|---|---|
| angle kappa based SBL-3 implantationSBL-3 implantation based on kappa angle guided by Callisto Eye System(Carl Zeiss Meditec, Germany) intraoperatively. | Procedure or surgery | design group |
| 0 to 180 degree SBL-3 implantationSBL-3 implantation in the direction of 0 to 180 degree guided by Callisto Eye System(Carl Zeiss Meditec, Germany) intraoperatively. | Procedure or surgery | control group |
Primary outcome
Uncorrected visual acuity
Time frame: 3 months postoperatively
Comparison of uncorrected distance visual acuity (UCVA), intermediate visual acuity, near visual acuity were measured at 5m, 80cm and 33cm respectively. All visual acuity measurements were conducted under photopic conditions (85 cd/m2) and at 100% contrast in design group and control group.
3 secondary outcomes
Optical quality
Time frame: 3 months postoperatively
Contrast sensitivity
Time frame: 3 months postoperatively
Defocus curve
Time frame: 3 months postoperatively
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 5 Aug 2022.
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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.
Hong Qi study director
Peking University Third Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing angle kappa based SBL-3 implantation and 0 to 180 degree SBL-3 implantation in people with Cataract, Age-Related, run by Peking University Third Hospital at 1 site in China.
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 6 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 5 Aug 2022. 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 China. 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?
Uncorrected visual acuity (time frame: 3 months postoperatively). 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 5 Aug 2022.