NCT04518696

Brief Summary

Study of novel surgical technic-suprachoroidal buckling for therapy of rhegmatogenous retinal detachment.It was excpted to reattached the retina and improve visual function of rhegmatogenous retinal detachment patients.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2020

Typical duration for not_applicable

Status
unknown

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

First Submitted

Initial submission to the registry

August 13, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 19, 2020

Completed
13 days until next milestone

Study Start

First participant enrolled

September 1, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2020

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

August 19, 2020

Status Verified

August 1, 2020

Enrollment Period

2 months

First QC Date

August 13, 2020

Last Update Submit

August 16, 2020

Conditions

Retinal Detachment

Outcome Measures

Primary Outcomes (4)

  • Retina reattachment

    Number of participants who achieved retina reattachment assessed by fundus photography，b-scan ultrasonography and optical coherence tomography.

    3 months post operation

  • Best Corrected visual Acuity (BCVA）

    Patients' best corrected visual acuity assessed by logarithmic visual acuity charts.

    3 months post operation

  • Intraocular pressure (IOP)

    Patients' IOP assessed by noncontact tonometer

    3 months post operation

  • Treatment-related adverse event

    Number of participants with treatment-related adverse events（including suprachoroidal hemorrhage, subretinal hemorrhage, vitreous hemorrhage）

    3 months post operation

Secondary Outcomes (4)

  • Retina reattachment

    12 months post operation

  • Best Corrected visual Acuity (BCVA）

    12 months post operation

  • Intraocular pressure (IOP)

    12 months post operation

  • Treatment-related adverse event

    12 months post operation

Study Arms (1)

suprachoroidal buckling treatment group

EXPERIMENTAL

suprachoroidal buckling for therapy of rhegmatogenous retinal detachment

Procedure: suprachoroidal buckling

Interventions

suprachoroidal bucklingPROCEDURE

Location, marking and freezing of the retinal tear on the scleral side . Subretinal fluid is released from the outside of the sclera as needed. In the quadrant of the retinal tear, the spherical conjunctiva was opened and the radial full-thickness scleral incision (3mm)was made about 8-13mm away from the retinal tear. After the choroid was exposed, a "pocket" is formed by injecting some viscoelastic agent into the posterior edge of the sclera and separating the choroid from the sclera using the Healon packaged cannula (No.27 Rycroft cannula). The Healon 5 syringe was connected with a 450-um special tube . The cannula is inserted into the supragromal space under microscopic and was scaned by iOCT . Once confirmed in accord with the needle position, sodium hyaluronate injection, usually need 0.2 mL to 0.5 mL, application of anterior chamber puncture or subretinal fluid stable intraocular pressure. Exit the duct and close the incision with scleral presutures.

suprachoroidal buckling treatment group

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • (1) Clinical diagnosis of rhegmatogenous retinal detachment; (2)myopia \< 600 degrees； (3) retinal tear were peripheral part, non-proliferative round hole or horseshoe tear, single or multiple tears within one oclock area; (4) PVR grading: Grade A, B, C1, C2; (5) Subretinal fluid was confined around the tear. (6)phakic.

You may not qualify if:

  • (1)Cataract, corneal degeneration, genetic diseases; (2)History of internal eye surgery; (3)The other eye was blind; (4)Postoperative follow-up could not be scheduled; (5)Systemic diseases (asthma, heart failure, myocardial infarction, liver failure, kidney failure and other serious diseases); (6)History of aspirin and other anticoagulant drugs; (7)Severe adverse reactions and systemic diseases occurred during follow-up.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • Antaki F, Dirani A, Ciongoli MR, Steel DHW, Rezende F. Hemorrhagic complications associated with suprachoroidal buckling. Int J Retina Vitreous. 2020 Apr 16;6:10. doi: 10.1186/s40942-020-00211-6. eCollection 2020.

    PMID: 32318273BACKGROUND

  • Szurman P, Boden K, Januschowski K. Suprachoroidal Hydrogel Buckling as a Surgical Treatment of Retinal Detachment: Biocompatibility and First Experiences. Retina. 2016 Sep;36(9):1786-90. doi: 10.1097/IAE.0000000000001116. No abstract available.

    PMID: 27429389RESULT

  • Mikhail M, El-Rayes EN, Kojima K, Ajlan R, Rezende F. Catheter-guided suprachoroidal buckling of rhegmatogenous retinal detachments secondary to peripheral retinal breaks. Graefes Arch Clin Exp Ophthalmol. 2017 Jan;255(1):17-23. doi: 10.1007/s00417-016-3530-8. Epub 2016 Nov 16.

    PMID: 27853956RESULT

  • El Rayes EN, Mikhail M, El Cheweiky H, Elsawah K, Maia A. SUPRACHOROIDAL BUCKLING FOR THE MANAGEMENT OF RHEGMATOGENOUS RETINAL DETACHMENTS SECONDARY TO PERIPHERAL RETINAL BREAKS. Retina. 2017 Apr;37(4):622-629. doi: 10.1097/IAE.0000000000001214.

    PMID: 27482642RESULT

  • Boden KT, Januschowski K, Szurman P. [Suprachoroidal Hydrogel Buckle - a New Minimal-Invasive Technique in Treatment of Rhegmatogenous Retinal Detachment]. Klin Monbl Augenheilkd. 2019 Mar;236(3):308-312. doi: 10.1055/s-0043-102947. Epub 2017 Apr 4. German.

    PMID: 28376555RESULT

MeSH Terms

Conditions

Retinal Detachment

Condition Hierarchy (Ancestors)

Retinal DiseasesEye Diseases

Study Officials

  • Fang Wang, MD,phD

    Department of ophthalmology, Shanghai Tenth People's Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Fang Wang, MD,phD

CONTACT

+86-1891768333518917683335@163.com

Conghui Zhang, MD,phD

CONTACT

+86-13671886466linghui0224@126.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Chief of department of ophthalmology

Study Record Dates

First Submitted

August 13, 2020

First Posted

August 19, 2020

Study Start

September 1, 2020

Primary Completion

October 31, 2020

Study Completion

December 31, 2022

Last Updated

August 19, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will share

Summarize the experience and deficiency of clinical research process and operation technology, and complete the preliminary report of clinical research.

Shared Documents
STUDY PROTOCOL, CSR
Time Frame
2021.01.31 The follow-up work of the study subjects was completed, and statistical analysis was conducted 2021.10.31 Continue to complete the follow-up of all patients, and make statistical analysis of all the data, and scientifically evaluate the results; Summarize the experience and deficiency of clinical research process and operation technology, and complete the preliminary report of clinical research.
Access Criteria
All access