Healaflow Patch for the Treatment of Rhegmatogenous Retinal Detachment

Not Applicable

Completed

• Conditions: Rhegmatogenous Retinal Detachment
• Interventions: Biological: Healaflow

• Registration Number: NCT03542162
• Lead Sponsor: 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.

Study Timeline

• Study Start: 2017-01-01
• Study First Submitted: 2018-05-17
• Study First Submitted QC: 2018-05-30
• Study First Posted: 2018-05-31
• Primary Completion: 2018-07-01
• Study Completion: 2018-12-01
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-29
• Last Update Posted: 2019-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Healaflow group	Healaflow	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.

Primary Outcome Measures

Name	Time	Method
postoperative anatomic outcome	baseline to 3 months post-surgery	fundus retina examination through ophthalmoscope, fundus image, B ultrosound

Secondary Outcome Measures

Name	Time	Method
BCVA	baseline to 3 months post-surgery	BCVA using a Landolt C acuity chart method
postoperative complications	baseline to 3 months post-surgery	postoperative complications