Healaflow Patch for the Treatment of Rhegmatogenous Retinal Detachment

NCT ID: NCT03542162

Last Updated: 2019-04-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-01
• Study Completion Date: 2018-12-01

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.

Conditions

Rhegmatogenous Retinal Detachment

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Healaflow

Intervention Type: BIOLOGICAL

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.

Interventions

Healaflow

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.

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion 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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Tianjin Medical University Eye Hospital

OTHER

Sponsor Role: lead

Responsible Party

Zhenchuan Zheng

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xiaorong Li, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Tianjin Medical University Eye Hospital

Other Identifiers

2016-KY18

Identifier Type: -

Identifier Source: org_study_id