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Macular HoleNCT03020459

Internal Limiting Membrane Peeling-reposition to Treat Idiopathic Macular Holes

A study testing peeling-reposition, peeling and Brilliant Blue G in people with Macular Hole and Surgery, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To compare the morphologic and functional outcomes of internal limiting membrane peeling-reposition versus peeling in idiopathic macular holes Read more about this study

Who is it for?
Ages 50 to 80 years
Conditions the study is for
Macular Hole, Surgery
What is being tested?
peeling-reposition, peeling and Brilliant Blue G
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteChina
Study dates
1 Jan 2017to 1 Aug 2019
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 50 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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.
Show all 15Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

    Shanghai, 200000

Other trials in China

About this study

Official title: Comparing the Surgical Outcomes of Internal Limiting Membrane Peeling-reposition Versus Peeling in Idiopathic Macular Holes: A Randomized Controlled Trial

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

Read the detailed description

This randomized clinical trial will be performed at a single center. Eligible patients with idiopathic macular holes will be equally randomized to internal limiting membrane (ILM) peeling-reposition group or ILM peeling group through computer-aided random allocation.

A standard 3-port pars plana vitrectomy was performed by a single surgeon using the Constellation 23 gauge vitrectomy system (Alcon Laboratories Inc, Fort Worth, Texas, USA).After posterior vitreous detachment was achieved, peeling of the ILM was performed by an end gripping forceps with the assistance of Brilliant Blue G. In ILM peeling-reposition group, the peeled ILM flap is flatten back to peeled area with assistance of perfluoro-n-octane. In ILM peeling group, a round shape with 2.5 to 3.5 disc diameter of ILM is peeled. This is followed by a complete fluid-gas exchange. Patients are encouraged to maintain a face-down position for two weeks postoperatively in two groups.

Postoperative measurements of BCVA and spectral domain optical coherence tomography(SD-OCT) are conducted at 1,3 and 6-month follow-up visits by independent masked observers. Macular light sensitivity and fixation stability are determined with microperimetry at 1,3, and 6 months of follow-up. Mf-ERG, M-score chart and VFQ-25 chart are performed 1,3, and 6 months of follow-up.

Comparison of BCVA, anatomical closure were primarily performed between the two groups. Then, the morphologic changes of inner retina and the functional parameters measured from microperimetry, Mf-ERG, M-score chart, VFQ-25 chart were analyzed.

Being tested
peeling-reposition, peeling, Brilliant Blue G, postoperative posture, Constellation 23-gauge vitrectomy system
Keywords
macular holes
Medical subject headings
Retinal Perforations

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • peeling-repositionProcedure or surgery

    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.

  • peelingProcedure or surgery

    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.

  • Brilliant Blue GDrug

    Also called BBG

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

  • postoperative postureOther

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

  • Constellation 23-gauge vitrectomy systemDevice

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

Study groups in NCT03020459
Study groupRoleWhat they receive
peeling-repositionExperimentalAfter 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.
Receives: Procedure: peeling-reposition; Drug: Brilliant Blue G; Other: postoperative posture; Device: Constellation 23-gauge vitrectomy system
peelingActive comparatorAfter 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.
Receives: Procedure: peeling; Drug: Brilliant Blue G; Other: postoperative posture; Device: Constellation 23-gauge vitrectomy system

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Best corrected visual acuity(BCVA)

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

    Measured: Pre-operation and 6 months after operation

Secondary outcomes (1)

  1. Close rate of macular holes

    Observed from optical coherence tomography

    Measured: 1 month after operation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jan 2017 (estimated)
  2. Study start1 Jan 2017
  3. Primary completion30 Jul 2019
  4. Study completion1 Aug 2019

Resources

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
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03020459
Sponsor's protocol ID
XH-16-049
Status last verified
Feb 2019
First submitted
11 Jan 2017
Last updated
13 May 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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

Publications

  • 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.

    PubMed 36695790

Questions about this trial

What is this clinical trial studying?

A study testing peeling-reposition, peeling and Brilliant Blue G in people with Macular Hole and Surgery, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.

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 3 inclusion and 15 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 13 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Best corrected visual acuity(BCVA) (time frame: Pre-operation and 6 months after operation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03020459, which also lists 1 linked publication.

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 13 May 2021.

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