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Healaflow Patch for the Treatment of Rhegmatogenous Retinal Detachment

NCT ID: NCT03542162

Last Updated: 2019-04-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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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

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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

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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

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Rhegmatogenous Retinal Detachment

Keywords

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Healaflow Rhegmatogenous retinal detachment 27-gauge Pars plana vitrectomy Minimally invasive surgery Complications

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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 Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

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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

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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

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Tianjin Medical University Eye Hospital

OTHER

Sponsor Role lead

Responsible Party

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Zhenchuan Zheng

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Xiaorong Li, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Tianjin Medical University Eye Hospital

Other Identifiers

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2016-KY18

Identifier Type: -

Identifier Source: org_study_id