Evaluation of the Rotational Stability
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|ClinicalTrials.gov Identifier: NCT03247751|
Recruitment Status : Completed
First Posted : August 14, 2017
Last Update Posted : February 20, 2018
Nidek Co. LTD.
Information provided by (Responsible Party):
Nidek Co. LTD.
To evaluate rotational stability of the investigational device implanted after cataract surgery.
|Condition or disease||Intervention/treatment||Phase|
|Cataract||Device: intraocular lens||Not Applicable|
The primary endpoint is angle of intraocular lens rotation between the day of surgery and postoperative 6 months.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||127 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Rotational Stability of the Blue Light-absorbing Hydrophobic Acrylic Posterior Chamber Single Piece Intraocular Lens|
|Actual Study Start Date :||June 2016|
|Actual Primary Completion Date :||August 2017|
|Actual Study Completion Date :||November 2017|
Experimental: one group
one group receiving NIDEK intraocular lens
Device: intraocular lens
Implant NIDEK intraocular lens after cataract surgery
Primary Outcome Measures :
- The intraocular lens rotation [ Time Frame: postoperative 6 months ]The angle of the intraocular rotation.
Secondary Outcome Measures :
- visual acuity [ Time Frame: postoperative 6 months ]Distance BCVA
- Adverse event [ Time Frame: postoperative 6 months ]severity and causal relationship
No Contacts or Locations Provided