NCT03542162

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2017

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

May 17, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

May 31, 2018

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

April 30, 2019

Status Verified

April 1, 2019

Enrollment Period

1.5 years

First QC Date

May 17, 2018

Last Update Submit

April 29, 2019

Conditions

Rhegmatogenous Retinal Detachment

Keywords

HealaflowRhegmatogenous retinal detachment27-gauge Pars plana vitrectomyMinimally invasive surgeryComplications

Outcome Measures

Primary Outcomes (1)

  • postoperative anatomic outcome

    fundus retina examination through ophthalmoscope, fundus image, B ultrosound

    baseline to 3 months post-surgery

Secondary Outcomes (2)

  • BCVA

    baseline to 3 months post-surgery

  • postoperative complications

    baseline to 3 months post-surgery

Study Arms (1)

Healaflow group

EXPERIMENTAL

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.

Biological: Healaflow

Interventions

HealaflowBIOLOGICAL

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.

Healaflow group

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Xiaorong Li, MD, PhD

    Tianjin Medical University Eye Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: All patients who meet the criteria and agree to paticipate in the clinical study, will be enrolled to this study after signing informed consent.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

May 17, 2018

First Posted

May 31, 2018

Study Start

January 1, 2017

Primary Completion

July 1, 2018

Study Completion

December 1, 2018

Last Updated

April 30, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share