Comparison of Optical Quality With Different Placement of Refractive Multifocal Intraocular Lens
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03674840|
Recruitment Status : Recruiting
First Posted : September 18, 2018
Last Update Posted : September 18, 2018
|Condition or disease||Intervention/treatment||Phase|
|Cataract, Age-Related||Procedure: angle kappa based SBL-3 implantation Procedure: 0 to 180 degree SBL-3 implantation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Intervention 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|
|Official Title:||Comparison of Optical Quality With Different Placement of Refractive Multifocal Intraocular Lens|
|Actual Study Start Date :||June 12, 2017|
|Estimated Primary Completion Date :||October 1, 2018|
|Estimated Study Completion Date :||October 1, 2018|
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.
Procedure: 0 to 180 degree SBL-3 implantation
SBL-3 implantation in the direction of 0 to 180 degree guided by Callisto Eye System(Carl Zeiss Meditec, Germany) intraoperatively.
Experimental: design group
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.
Procedure: angle kappa based SBL-3 implantation
SBL-3 implantation based on kappa angle guided by Callisto Eye System(Carl Zeiss Meditec, Germany) intraoperatively.
- 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.
- Optical quality [ Time Frame: 3 months postoperatively ]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.
- Contrast sensitivity [ Time Frame: 3 months postoperatively ]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.
- Defocus curve [ Time Frame: 3 months postoperatively ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03674840
|Contact: Yiyun Liufirstname.lastname@example.org|
|Peking University Third Hospital||Recruiting|
|Beijing, Beijing, China, 100191|
|Contact: Hong Qi email@example.com|
|Study Director:||Hong Qi||Peking University Third Hospital|