An observational study in Refractive Errors, sponsored by Dietrich-Bonhoeffer-Klinikum. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-09-26.
Sponsored by Dietrich-Bonhoeffer-Klinikum · Observational
This Study determines the most precise method for measuring post-operative refraction following implantation of the asymmetric multifocal LS-313 MF30 comparing the results of Refraction of the different Autorefractor Keratometers with the subjective measurements for distance and near.
This is a post market study without invasive interventions. The patients have been treated with cataract surgery and MIOL Implantation at least 3 months ago. They will be invited for only one follow up visit to measure the postoperative refraction with different Autorefractor-Keratometers, a Manual Refractometer, the test device "iTrace" and with determination of the subjective refraction for distance and near with the appropriate corrections at the Department of Ophthalmology in Neubrandenburg, Germany.
up to 100 eyes
Patients after cataract surgery with implantation of the MICS-IOL LS-313 MF30 postoperative clear cornea willing to participate in the study
Exclusion Criteria:
significant corneal opacities, history of keratoplasty, Anterior capsule phimosis, posterior capsular opacification if patients refuse Nd:YAG laser treatment of the secondary cataract
Patients who have undergone a cataract surgery with implantation of a multifocal intraocular lens LS313 MF30, Oculentis Berlin, will be invited for Measurements of the postoperative refraction
Diagnostic Test: Measurements of the postoperative refraction
The Measurements of the postoperative refraction will be performed with the following devices: Autorefractor Keratometers: Mod. ARK-760A (NIDEK CO,LTD, Gamagõri, Japan /OCULUS, Wetzlar, Germany), Mod. ARK-560A (NIDEK CO,LTD, Gamagõri, Japan /OCULUS, Wetzlar, Germany) KR-1W (TOPCON, Willich, Germany) KR-800s (TOPCON, Willich, Germany) Manual Refractometer: Eye refractometer PR 60 or PR 50 (Rodenstock, Munich), Test device: iTrace (TraceyTechnologies, Houston, Texas, USA), Phoropter (Block-Optic, Model 11625B) Determination of subjective refraction for distance and near (reading distance)
Evaluation of the Most Precise Method for Measuring Post-operative Refraction Following Implantation of the Asymmetric Multifocal LS-313 MF30
After the implantation of the LS 313 MF30 (a refractive, asymmetrical, multifocal intraocular lens), the most reliable refraction method so far has been the subjective determination of far and near refraction. A faster and widespread method is the measurement with auto-refractometers (KR-1W (TOPCON), KR-800s (TOPCON), ARK-560 (NIDEK), ARK-760A (NIDEK)) or manual refractometers (PR60/50 (Rodenstock)). KR-1W, KR-800s, ARK-560A, ARK-760A only allow a central measurement without separate measurement of the two optical zones. The manual refractometer PR60/50 (Rodenstock) is able to separately measure the different focal points of the multifocal lens using a light cone with 3 mm diameter. The test device iTrace (TraceyTechnologies): is also able to separately measure the different focal points of the multifocal lens, but uses a light cone with a diameter of about 1 mm. The results of all refractometers are compared with the subjective refraction.
Time frame: one year
| Milestone | Multifocal Intraocular Lens Implantation |
|---|---|
| Started | 25 |
| Completed | 25 |
| Not completed | 0 |
After the implantation of the LS 313 MF30 (a refractive, asymmetrical, multifocal intraocular lens), the most reliable refraction method so far has been the subjective determination of far and near refraction. A faster and widespread method is the measurement with auto-refractometers (KR-1W (TOPCON), KR-800s (TOPCON), ARK-560 (NIDEK), ARK-760A (NIDEK)) or manual refractometers (PR60/50 (Rodenstock)). KR-1W, KR-800s, ARK-560A, ARK-760A only allow a central measurement without separate measurement of the two optical zones. The manual refractometer PR60/50 (Rodenstock) is able to separately measure the different focal points of the multifocal lens using a light cone with 3 mm diameter. The test device iTrace (TraceyTechnologies): is also able to separately measure the different focal points of the multifocal lens, but uses a light cone with a diameter of about 1 mm. The results of all refractometers are compared with the subjective refraction.
| diopter | Multifocal Intraocular Lens Implantation |
|---|---|
| subjective Refraction | 0.36 ± 0.65 |
| iTrace | 0.27 ± 0.64 |
| KR-W1 | -0.81 ± 0.59 |
| KR-800s | -0.78 ± 0.73 |
| ARK-760A | -0.73 ± 0.59 |
| ARK-560A | -0.76 ± 0.63 |
| PR60/50 | -0.18 ± 0.43 |
Collected over 1 month. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Multifocal Intraocular Lens Implantation | 0/25 (0%) | 0/25 (0%) | 0/25 (0%) |
| Age, Categorical(Participants) | Multifocal Intraocular Lens Implantation |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 5 |
| >=65 years | 20 |
| Age, Continuous(years) | Multifocal Intraocular Lens Implantation |
|---|---|
| Mean | 69.84 ± 8.19 |
| Sex: Female, Male(Participants) | Multifocal Intraocular Lens Implantation |
|---|---|
| Female | 11 |
| Male | 14 |
| Race and Ethnicity Not Collected(Participants) | Multifocal Intraocular Lens Implantation |
|---|
| Region of Enrollment(participants) | Multifocal Intraocular Lens Implantation |
|---|---|
| Germany | 25 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — Results will be published in ophthalmological journals (Individual participant date will not be provided).
This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.
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Dietrich-Bonhoeffer-Klinikum