Rhegmatogenous Retinal DetachmentNCT03542162
Healaflow Patch for the Treatment of Rhegmatogenous Retinal Detachment
A study testing Healaflow in people with Rhegmatogenous Retinal Detachment, run by Tianjin Medical University Eye Hospital.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Rhegmatogenous Retinal Detachment
- What is being tested?
- Healaflow
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2017to 1 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
None listed.
About this study
Official title: Patching Retinal Breaks With Healaflow in 27G Vitrectomy for the Treatment of Rhegmatogenous Retinal Detachment
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.
Read the 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
- Being tested
- Healaflow
- Keywords
- Healaflow, Rhegmatogenous retinal detachment, 27-gauge Pars plana vitrectomy, Minimally invasive surgery, Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: Healaflow |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative anatomic outcome
fundus retina examination through ophthalmoscope, fundus image, B ultrosound
Measured: baseline to 3 months post-surgery
Secondary outcomes (2)
BCVA
BCVA using a Landolt C acuity chart method
Measured: baseline to 3 months post-surgery
postoperative complications
postoperative complications
Measured: baseline to 3 months post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2018
- Study start1 Jan 2017
- Primary completion1 Jul 2018
- Study completion1 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rhegmatogenous Retinal DetachmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tianjin Medical University Eye Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhenchuan Zheng, Tianjin Medical University Eye Hospital
- Investigators
- Xiaorong Li, MD, PhD, Principal investigator, Tianjin Medical University Eye Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03542162
- Sponsor's protocol ID
- 2016-KY18
- Status last verified
- Apr 2019
- First submitted
- 17 May 2018
- Last updated
- 30 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patching Retinal Breaks With Healaflow in 27G Vitrectomy for the Treatment of Rhegmatogenous Retinal Detachment
- ClinicalTrials.gov ID
- NCT03542162
- Acronym / sponsor ID
- 2016-KY18
- Conditions
- Rhegmatogenous Retinal Detachment
- Keywords
- Healaflow, Rhegmatogenous retinal detachment, 27-gauge Pars plana vitrectomy, Minimally invasive surgery, Complications
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Tianjin Medical University Eye HospitalUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 Jul 2018 (actual)
- Study completion
- 1 Dec 2018 (actual)
- First posted
- 31 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Healaflow group | Experimental | Biological: HealaflowThe 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HealaflowFor 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. | Biological | Healaflow group |
Primary outcome
postoperative anatomic outcome
Time frame: baseline to 3 months post-surgery
fundus retina examination through ophthalmoscope, fundus image, B ultrosound
2 secondary outcomes
BCVA
Time frame: baseline to 3 months post-surgery
postoperative complications
Time frame: baseline to 3 months post-surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiaorong Li, MD, PhD principal investigator
Tianjin Medical University Eye Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Healaflow in people with Rhegmatogenous Retinal Detachment, run by Tianjin Medical University Eye Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative anatomic outcome (time frame: baseline to 3 months post-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2019.