Comparative Analysis of Large Macular Hole Surgeries (CAOLMHS)
Primary Purpose
Macular Holes
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
the Cover group
the Fill group
the peeling group
Sponsored by
About this trial
This is an interventional treatment trial for Macular Holes focused on measuring Inverted Internal Limiting Membrane Flap Technique, Large Macular Hole, Macular hole surgery
Eligibility Criteria
Inclusion Criteria:
- idiopathic MHs, a minimum hole diameter of ≥ 400 μm, and follow-up for at least 3 months after vitrectomy.
Exclusion Criteria:
- High myopia (≥6 diopters,AL≥26.5mm), increased intraocular pressure (IOP, >21 mm Hg) or glaucoma, severe cataract, severe systemic conditions that prevent surgery, and history of ocular trauma, intraocular inflammation, retinal vascular disease, or previous ocular surgery.
Sites / Locations
- Department of Ophthalmology, The Second Affiliated Hospital, Zhejiang University School of MedicineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
the peeling group
the Cover group
the Fill group
Arm Description
the internal limiting membrane was discarded
the internal limiting membrane was peeled centripetally all the way up to the MH rim and the hinged ILM flap folded upside-down on top of the MH in order to bridge the entire retinal defect with a single layer.
the internal limiting membrane was folded in multiple layers and deliberately "stuffed" or "packed" within the MH defect using a forceps.
Outcomes
Primary Outcome Measures
MH status
MH status (open, flat open or closed)
IS/OS line interruption width
IS/OS line interruption width were gauged with spectral-domain optical coherence tomography
Change from Baseline IS/OS line interruption width at 3 months
IS/OS line interruption width were gauged with spectral-domain optical coherence tomography
Baseline best-corrected visual acuity
best-corrected visual acuity were gauged with EDTRS charts,recorded in decimals and was converted to logarithm of the minimum angle of resolution units for statistical analysis
Change from Baseline best-corrected visual acuity at 3 months
best-corrected visual acuity were gauged with EDTRS charts,recorded in decimals and was converted to logarithm of the minimum angle of resolution units for statistical analysis
visual function
visual function were gauged with national eye institute visual function questionnaire-25((NEI VFQ-25)
Change from Baseline visual function at 3 months
visual function were gauged with national eye institute visual function questionnaire-25((NEI VFQ-25)
Secondary Outcome Measures
Full Information
NCT ID
NCT04116892
First Posted
September 29, 2019
Last Updated
October 25, 2020
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
1. Study Identification
Unique Protocol Identification Number
NCT04116892
Brief Title
Comparative Analysis of Large Macular Hole Surgeries
Acronym
CAOLMHS
Official Title
Prospective, Consecutive, Non-randomized,Interventional Trial of Comparative Analysis of Large Macular Hole Surgeries
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
May 1, 2019 (Actual)
Primary Completion Date
June 30, 2021 (Anticipated)
Study Completion Date
September 30, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study compares the anatomical and visual outcomes in a large series of patients affected by idiopathic macular holes larger than 400 µm treated using pars plana vitrectomy and gas tamponade combined with internal limiting membrane (ILM) peeling or the inverted internal limiting membrane flap technique. A part of the participants will receive internal limiting membrane peeling,whil the other will receive the inverted internal limiting membrane flap technique.
Detailed Description
Vitrectomy is the standard treatment for idiopathic macular holes (IMHs) and is combined with removal of the internal limiting membrane (ILM) to improve anatomical outcomes.However, surgical closure is not achieved after a single operation in all cases, and patients with long-standing MHs or highly myopic eyes are challenging to treat.Various surgical strategies have been introduced to improve postoperative outcomes for these cases. Michalewska et al. have reported an inverted ILM flap technique for large MHs. The ILM around the MH was left to cover or fill the hole and showed a better anatomical closure rate and visual outcome than ILM peeling for large MHs. Nevertheless, the functional and anatomic outcomes of the ILM flap technique have not been investigated as extensively as the ILM peeling technique and have yet to be confirmed by research comparing the ILM flap technique with the conventional procedure.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Macular Holes
Keywords
Inverted Internal Limiting Membrane Flap Technique, Large Macular Hole, Macular hole surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Non-Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
the peeling group
Arm Type
Active Comparator
Arm Description
the internal limiting membrane was discarded
Arm Title
the Cover group
Arm Type
Experimental
Arm Description
the internal limiting membrane was peeled centripetally all the way up to the MH rim and the hinged ILM flap folded upside-down on top of the MH in order to bridge the entire retinal defect with a single layer.
Arm Title
the Fill group
Arm Type
Experimental
Arm Description
the internal limiting membrane was folded in multiple layers and deliberately "stuffed" or "packed" within the MH defect using a forceps.
Intervention Type
Procedure
Intervention Name(s)
the Cover group
Intervention Description
The internal limiting membrane around the MH was left to cover the hole
Intervention Type
Procedure
Intervention Name(s)
the Fill group
Intervention Description
The internal limiting membrane around the MH was left to fill the hole
Intervention Type
Procedure
Intervention Name(s)
the peeling group
Intervention Description
the internal limiting membrane was discarded
Primary Outcome Measure Information:
Title
MH status
Description
MH status (open, flat open or closed)
Time Frame
at 3 months after surgery
Title
IS/OS line interruption width
Description
IS/OS line interruption width were gauged with spectral-domain optical coherence tomography
Time Frame
at 3 months after surgery
Title
Change from Baseline IS/OS line interruption width at 3 months
Description
IS/OS line interruption width were gauged with spectral-domain optical coherence tomography
Time Frame
at 3 months after surgery
Title
Baseline best-corrected visual acuity
Description
best-corrected visual acuity were gauged with EDTRS charts,recorded in decimals and was converted to logarithm of the minimum angle of resolution units for statistical analysis
Time Frame
at 3 months after surgery
Title
Change from Baseline best-corrected visual acuity at 3 months
Description
best-corrected visual acuity were gauged with EDTRS charts,recorded in decimals and was converted to logarithm of the minimum angle of resolution units for statistical analysis
Time Frame
at 3 months after surgery
Title
visual function
Description
visual function were gauged with national eye institute visual function questionnaire-25((NEI VFQ-25)
Time Frame
at 3 months after surgery
Title
Change from Baseline visual function at 3 months
Description
visual function were gauged with national eye institute visual function questionnaire-25((NEI VFQ-25)
Time Frame
at 3 months after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
idiopathic MHs, a minimum hole diameter of ≥ 400 μm, and follow-up for at least 3 months after vitrectomy.
Exclusion Criteria:
High myopia (≥6 diopters,AL≥26.5mm), increased intraocular pressure (IOP, >21 mm Hg) or glaucoma, severe cataract, severe systemic conditions that prevent surgery, and history of ocular trauma, intraocular inflammation, retinal vascular disease, or previous ocular surgery.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhiyong Zhang, docter
Phone
13968059392
Email
zhangziyongnet@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tao Jiang
Organizational Affiliation
Second Affiliated Hospital, School of Medicine, Zhejiang University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Ophthalmology, The Second Affiliated Hospital, Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhiyong Zhang, docter
Phone
13968059392
Email
zhangziyongnet@163.com
12. IPD Sharing Statement
Plan to Share IPD
No
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Comparative Analysis of Large Macular Hole Surgeries
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