Healaflow Patch for the Treatment of Rhegmatogenous Retinal Detachment

Patching Retinal Breaks With Healaflow in 27G Vitrectomy for the Treatment of Rhegmatogenous Retinal Detachment

Sponsors

Lead Sponsor: Tianjin Medical University Eye Hospital

Source Tianjin Medical University Eye Hospital
Brief Summary

To report the surgical results of primary rhegmatogenous retinal detachment (RRD) repaired by 27G pars plana vitrectomy (PPV) combined with Healaflow patch and air tamponade, and do not need prone position postoperation.

Detailed Description

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.

Overall Status Completed
Start Date January 1, 2017
Completion Date December 1, 2018
Primary Completion Date July 1, 2018
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
postoperative anatomic outcome baseline to 3 months post-surgery
Secondary Outcome
Measure Time Frame
BCVA baseline to 3 months post-surgery
postoperative complications baseline to 3 months post-surgery
Enrollment 37
Condition
Intervention

Intervention Type: Biological

Intervention Name: Healaflow

Description: 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.

Arm Group Label: Healaflow group

Eligibility

Criteria:

Inclusion Criteria: - patients with primary RRD

Exclusion Criteria: - 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

Gender: All

Minimum Age: N/A

Maximum Age: N/A

Healthy Volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Xiaorong Li, MD, PhD Principal Investigator Tianjin Medical University Eye Hospital
Verification Date

April 2019

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Tianjin Medical University Eye Hospital

Investigator Full Name: Zhenchuan Zheng

Investigator Title: Principal investigator

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: Healaflow group

Type: Experimental

Description: 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.

Patient Data No
Study Design Info

Allocation: N/A

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.

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov