Measurement of Refractive SE Following Implantation of LS313 MF30 IOL
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
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 |
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)
|
Outcome Measures
Primary Outcome Measures
- 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.
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Dietrich-Bonhoeffer-Klinikum | Neubrandenburg | Mecklenburg/Vorpommern | Germany | 17036 |
Sponsors and Collaborators
- Dietrich-Bonhoeffer-Klinikum
Investigators
- Principal Investigator: Helmut Hoeh, MD, FEBO, Department of Ophthalmology, Neubrandenburg, Germany
- Study Chair: Vitaliy Klishko, Department of Ophthalmology, Neubrandenburg, Germany
Study Documents (Full-Text)
More Information
Publications
- Bissen-Miyajima H, Minami K, Yoshino M, Nishimura M, Oki S. Autorefraction after implantation of diffractive multifocal intraocular lenses. J Cataract Refract Surg. 2010 Apr;36(4):553-6. doi: 10.1016/j.jcrs.2009.10.047.
- Kretz FT, Linz K, Mueller M, Gerl M, Koss MJ, Gerl RH, Auffarth GU. [Refraction after Implantation of Multifocal and Presbyopia-Correcting Intraocular Lenses]. Klin Monbl Augenheilkd. 2015 Aug;232(8):953-6. doi: 10.1055/s-0035-1545832. Epub 2015 Apr 30. Review. German.
- Muñoz G, Albarrán-Diego C, Sakla HF. Autorefraction after multifocal IOLs. Ophthalmology. 2007 Nov;114(11):2100.
- Muñoz G, Albarrán-Diego C, Sakla HF. Validity of autorefraction after cataract surgery with multifocal ReZoom intraocular lens implantation. J Cataract Refract Surg. 2007 Sep;33(9):1573-8.
- van der Linden JW, Vrijman V, Al-Saady R, van der Meulen IJ, Mourits MP, Lapid-Gortzak R. Autorefraction versus subjective refraction in a radially asymmetric multifocal intraocular lens. Acta Ophthalmol. 2014 Dec;92(8):764-8. doi: 10.1111/aos.12410. Epub 2014 Apr 27. Erratum in: Acta Ophthalmol. 2015 Feb;93(1):e82. El-Saady, Rana [corrected to Al-Saady, Rana].
- STI 02/17
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail |
Arm/Group Title | Multifocal Intraocular Lens Implantation |
---|---|
Arm/Group Description | 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 |
Period Title: Overall Study | |
STARTED | 25 |
COMPLETED | 25 |
NOT COMPLETED | 0 |
Baseline Characteristics
Arm/Group Title | Multifocal Intraocular Lens Implantation |
---|---|
Arm/Group Description | 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 |
Overall Participants | 25 |
Age (Count of Participants) | |
<=18 years |
0
0%
|
Between 18 and 65 years |
5
20%
|
>=65 years |
20
80%
|
Age (years) [Mean (Standard Deviation) ] | |
Mean (Standard Deviation) [years] |
69.84
(8.19)
|
Sex: Female, Male (Count of Participants) | |
Female |
11
44%
|
Male |
14
56%
|
Race and Ethnicity Not Collected (Count of Participants) | |
Region of Enrollment (participants) [Number] | |
Germany |
25
100%
|
Outcome Measures
Title | Evaluation of the Most Precise Method for Measuring Post-operative Refraction Following Implantation of the Asymmetric Multifocal LS-313 MF30 |
---|---|
Description | 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 |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Multifocal Intraocular Lens Implantation |
---|---|
Arm/Group Description | 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 |
Measure Participants | 25 |
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)
|
Adverse Events
Time Frame | 1 month | |
---|---|---|
Adverse Event Reporting Description | Adverse events that may occur in the course of this study are glare sensitivity, allergic reaction, continuous dilation over 2 to 3 days (in Mydriasis) or accident on the way to the investigations. | |
Arm/Group Title | Multifocal Intraocular Lens Implantation | |
Arm/Group Description | 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 | |
All Cause Mortality |
||
Multifocal Intraocular Lens Implantation | ||
Affected / at Risk (%) | # Events | |
Total | 0/25 (0%) | |
Serious Adverse Events |
||
Multifocal Intraocular Lens Implantation | ||
Affected / at Risk (%) | # Events | |
Total | 0/25 (0%) | |
Other (Not Including Serious) Adverse Events |
||
Multifocal Intraocular Lens Implantation | ||
Affected / at Risk (%) | # Events | |
Total | 0/25 (0%) |
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title | Ulrike Holland |
---|---|
Organization | Dietrich-Bonhoeffer-Klinikum |
Phone | +49 395 775 3427 |
aug-st2@dbknb.de |
- STI 02/17