Prospective Clinical Trial of Unilateral or Bilateral Implantation of TecnisSymfony IOL in Cataract Patients With Presbyopia
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|ClinicalTrials.gov Identifier: NCT03501654|
Recruitment Status : Active, not recruiting
First Posted : April 18, 2018
Last Update Posted : April 18, 2018
|Condition or disease||Intervention/treatment||Phase|
|Cataract Presbyopia||Device: TecnisSymfony®||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prospective Clinical Trial of Unilateral or Bilateral Implantation of the Enlarged Depth-of-focus Intraocular Lens in Cataract Patients With Presbyopia|
|Actual Study Start Date :||February 17, 2017|
|Estimated Primary Completion Date :||May 2018|
|Estimated Study Completion Date :||December 2018|
|Experimental: TecnisSymfony intraocular lens insertion group||
Patients received implantation of unilateral or bilateral TecnisSymfony® IOL after phacoemulsification by a single surgeon (MK Kim).
- Change of visual acuity at near, intermediate and far [ Time Frame: preoperative(last outpatient follow-up before the surgery), 1 month after surgery, 3 months after surgery. ]LogMAR visual acuity (logMARVA) at the distance (5m), intermediate (66cm), and near (40cm) were measured at preoperative (last outpatient follow-up before the surgery), postoperative 1, 4, and 12 weeks.
- Photic phenomena evaluation by questionnaire. [ Time Frame: One month and three months after the surgery. ]Patients were asked if they had subjective glare or halo (scale: mild, moderate, severe).
- Spectacle dependence evaluation by questionnaire [ Time Frame: One month and three months after the surgery. ]Patients were asked for 0, 25, 50, 75, and 100% of the need to wear glasses at distance, mid-range, and near distance.
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): NCT03501654
|Korea, Republic of|
|Seoul National University Hospital|
|Seoul, Korea, Republic of, 03080|
|Principal Investigator:||Mee Kum Kim, M.D., Ph.D.||Seoul National University Hospital|