Trial Outcomes & Findings for Measurement of Refractive SE Following Implantation of LS313 MF30 IOL (NCT NCT03292614)

NCT ID: NCT03292614

Last Updated: 2019-09-26

Results Overview

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.

• Recruitment status: COMPLETED
• Target enrollment: 25 participants
• Primary outcome timeframe: one year
• Results posted on: 2019-09-26

Participant Flow

Participant milestones

Measure	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
Overall Study STARTED	25
Overall Study COMPLETED	25
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Multifocal Intraocular Lens Implantation n=25 Participants 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
Age, Categorical <=18 years	0 Participants n=25 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=25 Participants
Age, Categorical >=65 years	20 Participants n=25 Participants
Age, Continuous	69.84 years STANDARD_DEVIATION 8.19 • n=25 Participants
Sex: Female, Male Female	11 Participants n=25 Participants
Sex: Female, Male Male	14 Participants n=25 Participants
Region of Enrollment Germany	25 participants n=25 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Multifocal Intraocular Lens Implantation n=25 Participants 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
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
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
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
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
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
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
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

Adverse Events

Multifocal Intraocular Lens Implantation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Ulrike Holland

Dietrich-Bonhoeffer-Klinikum

Phone: +49 395 775 3427

Email: aug-st2@dbknb.de

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place