Refractive Errors
Conditions
Keywords
Multifocal Intraocular Lens, Postoperative Measurements of refraction
Brief summary
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.
Detailed description
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.
Interventions
DIAGNOSTIC_TESTMeasurements 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)
Sponsors
Dietrich-Bonhoeffer-Klinikum
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of the Most Precise Method for Measuring Post-operative Refraction Following Implantation of the Asymmetric Multifocal LS-313 MF30 | one year | 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. |
Countries
Germany
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Multifocal Intraocular Lens Implantation 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 | 25 |
| Total | 25 |
Baseline characteristics
| Characteristic | Multifocal Intraocular Lens Implantation | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 20 Participants | — |
| Age, Categorical Between 18 and 65 years | 5 Participants | — |
| Age, Continuous | 69.84 years STANDARD_DEVIATION 8.19 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Germany | 25 participants | — |
| Sex: Female, Male Female | 11 Participants | — |
| Sex: Female, Male Male | 14 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 25 |
| other Total, other adverse events | 0 / 25 |
| serious Total, serious adverse events | 0 / 25 |
Outcome results
Primary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Multifocal Intraocular Lens Implantation | Evaluation of the Most Precise Method for Measuring Post-operative Refraction Following Implantation of the Asymmetric Multifocal LS-313 MF30 | subjective Refraction | 0.36 diopter | Standard Deviation 0.65 |
| Multifocal Intraocular Lens Implantation | Evaluation of the Most Precise Method for Measuring Post-operative Refraction Following Implantation of the Asymmetric Multifocal LS-313 MF30 | iTrace | 0.27 diopter | Standard Deviation 0.64 |
| Multifocal Intraocular Lens Implantation | Evaluation of the Most Precise Method for Measuring Post-operative Refraction Following Implantation of the Asymmetric Multifocal LS-313 MF30 | KR-W1 | -0.81 diopter | Standard Deviation 0.59 |
| Multifocal Intraocular Lens Implantation | Evaluation of the Most Precise Method for Measuring Post-operative Refraction Following Implantation of the Asymmetric Multifocal LS-313 MF30 | KR-800s | -0.78 diopter | Standard Deviation 0.73 |
| Multifocal Intraocular Lens Implantation | Evaluation of the Most Precise Method for Measuring Post-operative Refraction Following Implantation of the Asymmetric Multifocal LS-313 MF30 | ARK-760A | -0.73 diopter | Standard Deviation 0.59 |
| Multifocal Intraocular Lens Implantation | Evaluation of the Most Precise Method for Measuring Post-operative Refraction Following Implantation of the Asymmetric Multifocal LS-313 MF30 | ARK-560A | -0.76 diopter | Standard Deviation 0.63 |
| Multifocal Intraocular Lens Implantation | Evaluation of the Most Precise Method for Measuring Post-operative Refraction Following Implantation of the Asymmetric Multifocal LS-313 MF30 | PR60/50 | -0.18 diopter | Standard Deviation 0.43 |