Macular HolesCAOLMHSNCT04116892
Comparative Analysis of Large Macular Hole Surgeries
A study testing the Cover group, the Fill group and the peeling group in people with Macular Holes, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Macular Holes
- What is being tested?
- the Cover group, the Fill group and the peeling group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2019to 30 Sep 2021
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- idiopathic MHs, a minimum hole diameter of ≥ 400 μm, and follow-up for at least 3 months after vitrectomy.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Ophthalmology, The Second Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang
Zhiyong Zhang, docter, 13968059392, zhangziyongnet@163.com
About this study
Official title: Prospective, Consecutive, Non-randomized,Interventional Trial of Comparative Analysis of Large Macular Hole Surgeries
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.
Read the 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.
- Conditions
- Macular Holes
- Being tested
- the Cover group, the Fill group, the peeling group
- Keywords
- Inverted Internal Limiting Membrane Flap Technique, Large Macular Hole, Macular hole surgery
- Medical subject headings
- Retinal Perforations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the Cover groupProcedure or surgery
The internal limiting membrane around the MH was left to cover the hole
the Fill groupProcedure or surgery
The internal limiting membrane around the MH was left to fill the hole
the peeling groupProcedure or surgery
the internal limiting membrane was discarded
| Study group | Role | What they receive |
|---|---|---|
| the peeling group | Active comparator | the internal limiting membrane was discarded Receives: Procedure: the peeling group |
| the Cover group | Experimental | 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. Receives: Procedure: the Cover group |
| the Fill group | Experimental | the internal limiting membrane was folded in multiple layers and deliberately "stuffed" or "packed" within the MH defect using a forceps. Receives: Procedure: the Fill group |
What is being measured
The primary outcome is the main question the study is designed to answer.
MH status
MH status (open, flat open or closed)
Measured: at 3 months after surgery
IS/OS line interruption width
IS/OS line interruption width were gauged with spectral-domain optical coherence tomography
Measured: at 3 months after surgery
Change from Baseline IS/OS line interruption width at 3 months
IS/OS line interruption width were gauged with spectral-domain optical coherence tomography
Measured: at 3 months after surgery
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
Measured: at 3 months after surgery
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
Measured: at 3 months after surgery
visual function
visual function were gauged with national eye institute visual function questionnaire-25((NEI VFQ-25)
Measured: at 3 months after surgery
Change from Baseline visual function at 3 months
visual function were gauged with national eye institute visual function questionnaire-25((NEI VFQ-25)
Measured: at 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2019
- Study start1 May 2019
- Primary completion30 Jun 2021 (estimated)
- Study completion30 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Macular HolesStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tao Jiang, Principal investigator, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04116892
- Sponsor's protocol ID
- IR001094
- Other IDs
- 2019-142
- Acronym
- CAOLMHS
- Status last verified
- Oct 2020
- First submitted
- 29 Sep 2019
- Last updated
- 27 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- 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 27 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Consecutive, Non-randomized,Interventional Trial of Comparative Analysis of Large Macular Hole Surgeries
- ClinicalTrials.gov ID
- NCT04116892
- Acronym / sponsor ID
- CAOLMHS / IR001094
- Conditions
- Macular Holes
- Keywords
- Inverted Internal Limiting Membrane Flap Technique, Large Macular Hole, Macular hole surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 30 Jun 2021 (estimated)
- Study completion
- 30 Sep 2021 (estimated)
- First posted
- 7 Oct 2019 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| the peeling group | Active comparator | Procedure: the peeling groupthe internal limiting membrane was discarded |
| the Cover group | Experimental | Procedure: the Cover groupthe 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 Fill group | Experimental | Procedure: the Fill groupthe internal limiting membrane was folded in multiple layers and deliberately "stuffed" or "packed" within the MH defect using a forceps. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- idiopathic MHs, a minimum hole diameter of ≥ 400 μm, and follow-up for at least 3 months after vitrectomy.
Key exclusion criteria (1 listed)
- 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.
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 |
|---|---|---|
| the Cover groupThe internal limiting membrane around the MH was left to cover the hole | Procedure or surgery | the Cover group |
| the Fill groupThe internal limiting membrane around the MH was left to fill the hole | Procedure or surgery | the Fill group |
| the peeling groupthe internal limiting membrane was discarded | Procedure or surgery | the peeling group |
Primary outcome
MH status
Time frame: at 3 months after surgery
MH status (open, flat open or closed)
IS/OS line interruption width
Time frame: at 3 months after surgery
IS/OS line interruption width were gauged with spectral-domain optical coherence tomography
Change from Baseline IS/OS line interruption width at 3 months
Time frame: at 3 months after surgery
IS/OS line interruption width were gauged with spectral-domain optical coherence tomography
Baseline best-corrected visual acuity
Time frame: at 3 months after surgery
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
Time frame: at 3 months after surgery
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
Time frame: at 3 months after surgery
visual function were gauged with national eye institute visual function questionnaire-25((NEI VFQ-25)
Change from Baseline visual function at 3 months
Time frame: at 3 months after surgery
visual function were gauged with national eye institute visual function questionnaire-25((NEI VFQ-25)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2020.
- 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.
Tao Jiang principal investigator
Second Affiliated Hospital, Zhejiang University, School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing the Cover group, the Fill group and the peeling group in people with Macular Holes, run by Second Affiliated Hospital, Zhejiang 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 27 Oct 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhiyong Zhang, docter (13968059392, zhangziyongnet@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MH status (time frame: at 3 months after surgery). The study lists 7 primary outcomes in all. 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 27 Oct 2020.