A Clinical Trial of The VisAbility Micro Insert System for Presbyopic Patients
|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. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02374671|
Recruitment Status : Active, not recruiting
First Posted : March 2, 2015
Last Update Posted : May 17, 2018
|Condition or disease||Intervention/treatment||Phase|
|Presbyopia||Device: VisAbility Micro Insert||Not Applicable|
The objective of this study is to evaluate the safety and effectiveness of the VisAbility Implant System (VIS) for the improvement of near visual acuity in presbyopic patients. This is a prospective clinical study that will enroll and determine eligible a total of 360 subjects ranging in age between 45 and 60 years of age at up to 14 clinical sites. Subjects will be implanted with the VisAbility Implant model SGP-046 in the primary eye and then in the fellow eye no sooner than 14 days later. Subjects will be examined at one day, one week and at 1, 2, 3, 6, 12, 18 and 24 months post-operatively.
The study will also include a 60 subject randomized controlled sub-study at 3 investigational sites. Subjects enrolled and eligible at these sites will be randomized (1:1 ratio) to a surgery group or a control group. Subjects randomized to the surgery group will undergo surgery and will be followed for 24 months in the same manner as the larger non-randomized surgical group. Subjects randomized to the control group will be followed for 6 months, and will be eligible to undergo surgery after completion of this 6-month follow-up period.
The primary endpoint is achievement of distance corrected near visual acuity (DCNVA) of Snellen equivalent 20/40 or better (at 40 cm) and at least 10 letters (ETDRS) improvement in DCNVA in the primary eye.
This endpoint will be evaluated against two objectives, a) 75% or more of primary eyes achieve the effectiveness endpoint at 12 months postoperative and b) the percentage of primary eyes achieving the effectiveness endpoint at 6 months postoperative (6-month responder rate) is higher than the percentage in the randomized control group.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||360 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Prospective, Multicenter Clinical Trial Of The VisAbility Micro Insert System For Improvement Of Near Visual Acuity In Presbyopic Patients|
|Study Start Date :||November 2014|
|Estimated Primary Completion Date :||May 2018|
|Estimated Study Completion Date :||May 2018|
Experimental: Treatment via Procedure/Surgery
The VisAbility Micro Insert treatment is for the improvement of near visual acuity in presbyopic patients. Subjects will receive the VisAbility Micro Inserts via a Procedure/Surgery.
Device: VisAbility Micro Insert
The VisAbility Micro Insert (Model SGP-046) is an injection molded curved scleral implant molded from PMMA (polymethylmethacrylate), a material with an extensive history of long-term implantation in the human eye, including intraocular lenses (IOLs). Four (4) VisAbility Micro Insert segments are placed in a single presbyopic eye to improve near vision.
- Distance Corrected Near Visual Acuity [ Time Frame: From date of randomization until the date of study withdrawal or study completion, whichever came first, assessed up to 2 years ]Achievement of distance corrected near visual acuity (DCNVA) of Snellen equivalent 20/40 or better (at 40 cm) and at least 10 letters (ETDRS) improvement in DCNVA in the primary eye.
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): NCT02374671
|United States, California|
|Orange, California, United States, 92868|
|Gordon Weiss Vision Institute|
|San Diego, California, United States, 92122|
|United States, Hawaii|
|Aloha Laser Vision|
|Honolulu, Hawaii, United States, 96814|
|United States, Illinois|
|The Midwest Center for Sight|
|Des Plaines, Illinois, United States, 60016|
|United States, Indiana|
|Eye Surgeons Of Indiana PC|
|Indianapolis, Indiana, United States, 46256|
|United States, Kentucky|
|Eye Care Institute|
|Louisville, Kentucky, United States, 40206|
|United States, Minnesota|
|Chu Vision Institute|
|Bloomington, Minnesota, United States, 55420|
|United States, New York|
|South Shore Eye Care LLP|
|Wantagh, New York, United States, 11793|
|United States, North Carolina|
|Greensboro, North Carolina, United States, 27401|
|United States, Ohio|
|Comprehensive EyeCare of Central Ohio|
|Westerville, Ohio, United States, 43082|
|United States, Pennsylvania|
|Bucci Laser Vision|
|Wilkes-Barre, Pennsylvania, United States, 18702|
|United States, Texas|
|Key Whitman Eye Center|
|Dallas, Texas, United States, 75242|
|Braverman-Terry-Oei Eye Associates|
|San Antonio, Texas, United States, 78212|
|Principal Investigator:||David Schanzlin, M.D.||Chief Medical Officer|