NCT03020459

Brief Summary

To compare the morphologic and functional outcomes of internal limiting membrane peeling-reposition versus peeling in idiopathic macular holes

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

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
10 days until next milestone

First Submitted

Initial submission to the registry

January 11, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 13, 2017

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2019

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2019

Completed
Last Updated

May 13, 2021

Status Verified

February 1, 2019

Enrollment Period

2.6 years

First QC Date

January 11, 2017

Last Update Submit

May 11, 2021

Conditions

Macular HoleSurgery

Keywords

macular holes

Outcome Measures

Primary Outcomes (1)

  • Best corrected visual acuity(BCVA)

    Change from baseline BCVA at 6 months after operation, examined with snellen chart.

    Pre-operation and 6 months after operation

Secondary Outcomes (1)

  • Close rate of macular holes

    1 month after operation

Other Outcomes (7)

  • Morphologic changes of inner retina

    1，3，6 months after operation

  • Central retinal thickness change

    Pre-operation and 1，3，6 months after operation

  • Mean foveal light sensitivity change

    Pre-operation and 1，3，6 months after operation

  • +4 more other outcomes

Study Arms (2)

peeling-reposition

EXPERIMENTAL

After dying with Brilliant Blue G (Brilliant Blue; Gender, Germany) with the help of Constellation 23-gauge vitrectomy system (Alcon Laboratories Inc, Fort Worth, TX), the intervention of "peeling-reposition" was used to peel and unfold the ILM. And the postoperative posture would be prone position in two weeks for all patients after the operation.

Procedure: peeling-repositionDrug: Brilliant Blue GOther: postoperative postureDevice: Constellation 23-gauge vitrectomy system

peeling

ACTIVE COMPARATOR

After dying with Brilliant Blue G (Brilliant Blue; Gender, Germany) with the help of Constellation 23-gauge vitrectomy system, the intervention of "peeling" was used to grasped ILM with end-gripping forceps. And the postoperative posture would be prone position in two weeks for all patients after the operation.

Procedure: peelingDrug: Brilliant Blue GOther: postoperative postureDevice: Constellation 23-gauge vitrectomy system

Interventions

peeling-repositionPROCEDURE

After dying with Brilliant Blue G (BBG, Brilliant Blue; Gender, Germany), a horizontal ILM strip is peeled off in inferior quadrant of macular area. Then the ILM was peeled from inferior to superior area continuously. The" ILM roll " was unfolded with assistance of perfluoro-n-octane (PFO). Finally, the position of the fixed ILM flap is adjusted under PFO bubble using flute needle or forceps.This was followed by a complete fluid-gas exchange using 14% perfluoropropane gas.Patients are introduced to maintain facedown position for two weeks postoperatively.

peeling-reposition
peelingPROCEDURE

After dying with Brilliant Blue G (Brilliant Blue; Gender, Germany), a horizontal ILM strip is peeled off in inferior quadrant of macular area. Then, the strand of ILM was peeled off radially from the foveal center to vascular arcade. In result, a round -shaped with 2.5-3.5 disc diameter ILM -peeled area was created.This was followed by a complete fluid-gas exchange using 14% perfluoropropane gas. Patients are encourage to maintain facedown position for two weeks postoperatively.

peeling
Brilliant Blue GDRUG

We intravitreal injected 0.1ml of Brilliant Blue G (Brilliant Blue; Gender, Germany) to dye ILM before ILM peeling.

Also known as: BBG
peelingpeeling-reposition
postoperative postureOTHER

Patients of both two groups need to keep prone position for two weeks after the operation.

peelingpeeling-reposition
Constellation 23-gauge vitrectomy systemDEVICE

All surgical procedures are operated on the Constellation 23-gauge vitrectomy system (Alcon Laboratories Inc, Fort Worth, TX).

peelingpeeling-reposition

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The patients are diagnosed as macular hole by optical coherence tomography.
  • Age ranges from 50 to 80 years.
  • The patients have indication for surgery.

You may not qualify if:

  • Traumatic macular hole.
  • Combined with serious epiretinal membrane.
  • Combined with diabetic retinopathy, hypertensive retinopathy.
  • Combined with other ocular diseases, such as keratitis，uveitis，retinal vasculitis.
  • \- 6.0 diopters or more of spherical equivalent, 26mm or more of axial length.
  • History of intraocular surgery.
  • Presence of staphyloma.
  • Other ocular diseases that could influence macular microstructure or visual function
  • Exit criteria:
  • For reposition group, the patients will exit the research if the peeled ILM cannot reposition successfully.
  • Due to adverse events, especially severe adverse events, the researchers consider withdrawal of patients based on concerns of safety and ethics;
  • Drop out;
  • The patients voluntarily withdraw the informed consent;
  • Serious violation of the study protocol due to the subjects or investigators' reasons;
  • Other reasons that the researchers believe for quitting the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, 200000, China

Location

Related Publications (1)

  • Tian T, Tan H, Zhu X, Zhang X, Zhao P. PEELED INTERNAL LIMITING MEMBRANE REPOSITION FOR IDIOPATHIC MACULAR HOLES: A Pilot Randomized Controlled Trial. Retina. 2023 Feb 1;43(2):191-199. doi: 10.1097/IAE.0000000000003645. Epub 2022 Oct 8.

    PMID: 36695790DERIVED

MeSH Terms

Conditions

Retinal Perforations

Interventions

Tooth Exfoliationcoomassie Brilliant Blue

Condition Hierarchy (Ancestors)

Retinal DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Dental Physiological PhenomenaDigestive System and Oral Physiological Phenomena

Study Officials

  • Peiquan Zhao, PhD

    Xin Hua Hospital Affiliated to Shanghai Jiaotong University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 11, 2017

First Posted

January 13, 2017

Study Start

January 1, 2017

Primary Completion

July 30, 2019

Study Completion

August 1, 2019

Last Updated

May 13, 2021

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will share

Individual participant data (IPD) will be shared after the end of this clinical trails.The data included patients' serial number, gender, age, laterality and all outcome measurement

Shared Documents
STUDY PROTOCOL, ICF
Time Frame
After enrollment completed; After the last followup of the last participant.

Locations

CN(1)