Healaflow Patch for the Treatment of Rhegmatogenous Retinal Detachment
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|ClinicalTrials.gov Identifier: NCT03542162|
Recruitment Status : Completed
First Posted : May 31, 2018
Last Update Posted : April 30, 2019
|Condition or disease||Intervention/treatment||Phase|
|Rhegmatogenous Retinal Detachment||Biological: Healaflow||Not Applicable|
To improve the success rates of pars plana vitrectomy(PPV) which is the most common surgical procedure for the repair of primary rhegmatogenous retinal detachment (RRD) and to avoid silicon oil tamponade and face-down position, all eyes enrolled into this clinical trail undergo 27G PPV combined with Healaflow patch and air tamponade which do not need face-down position in the postoperative period. Healaflow® (Anteis S.A., Plan Les Ouates, Switzerland) consists of over 97% water, sodium hyaluronic acid (22.5 mg/ml) of nonanimal origin cross-linked with BDDE (1.4-Butanediol diglycidyl ether), and phosphate- and NaCl-salts to maintain a physiological pH (7.0) and osmolarity (305 mOsm/kg).
At the time of study enrollment, physical examinations, best-corrected visual acuity (BCVA), intraocular pressure(IOP) will be measured and fundoscopy, OCT, B-ultrasound will be performed.
The patients are going to be followed up for at least 3 months, the main outcome measures are postoperative primary and final anatomic outcome, BCVA and complications.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||37 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||All patients who meet the criteria and agree to paticipate in the clinical study, will be enrolled to this study after signing informed consent.|
|Masking:||None (Open Label)|
|Official Title:||Patching Retinal Breaks With Healaflow in 27G Vitrectomy for the Treatment of Rhegmatogenous Retinal Detachment|
|Actual Study Start Date :||January 1, 2017|
|Actual Primary Completion Date :||July 1, 2018|
|Actual Study Completion Date :||December 1, 2018|
Experimental: Healaflow group
The Healaflow group consists of patients with primary RRD, but exclude proliferative vitreoretinopathy grade C or more, dialysis, retinoschisis, eyes with secondary RRD, significant corneal or lens opacity precluding vitrectomy, giant retinal tears, a follow-up period of less than 3 months, and visual loss from causes other than RRD.
For the RRD patients, after 27G PPV, air-liquid exchange and endolaser photocoagulation around the tear(s), Healaflow is going to be fully covered on the surface of all retinal tears using 27G needle, the amount of Healaflow injection was determined according to the size of tears.
- postoperative anatomic outcome [ Time Frame: baseline to 3 months post-surgery ]fundus retina examination through ophthalmoscope, fundus image, B ultrosound
- BCVA [ Time Frame: baseline to 3 months post-surgery ]BCVA using a Landolt C acuity chart method
- postoperative complications [ Time Frame: baseline to 3 months post-surgery ]postoperative complications
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): NCT03542162
|Principal Investigator:||Xiaorong Li, MD, PhD||Tianjin Medical University Eye Hospital|