Macular HolesNCT03888625
Compare the Healing Process of Idiopathic Macular Hole With Different Surgical Techniques
A study testing Conventional ILM Peeling and Inverted ILM Peeling in people with Macular Holes, run by Federal University of São Paulo at 1 site in Brazil.
Trial summary
To compare anatomic and functional results, and to evaluate postoperatively the healing process in 2 different techniques for the closure of the macular holes (MH) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Macular Holes
- What is being tested?
- Conventional ILM Peeling and Inverted ILM Peeling
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- 15 Jun 2018to 30 Jun 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- > Stage 3 and 4 macular holes with visual acuity between 20/30 and 20/800 according to the ETDRS chart.
Who cannot join
- Macular holes secondary to ocular trauma, myopia or retinal detachment
- Any previous treatment for the macular hole
- Evidence on examination of any diabetic retinopathy
- History or presence of wet or dry age macular degeneration (AMD)
- Presence of epiretinal membrane or prior uveitis
- Any ocular surgery within 3 months before baseline
- Intra or periocular infection
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Dept. of Ophthalmology
São Paulo, 04023-062
Mauricio Maia, MD, PhD, 1155764848 ext. 2265, maiamauricio@terra.com.br
Luci p Silva, PhD, MBA, 11971571967, luci.pesquisa@gmail.com
About this study
Official title: Randomized Clinical Trials to Compare the Healing Process of Idiopathic Macular Hole With Different Surgical Techniques
To compare anatomic and functional results, and to evaluate postoperatively the healing process in 2 different techniques for the closure of the macular holes (MH)
Read the detailed description
Patients with macular holes classified in stages 3 and 4 will be randomized into 2 groups. . In Group A, patients will undergo peeling with complete removal of the internal limiting membrane (ILM) and in the group B, the inverted ILM peeling technique will be performed. The 20% sulfur hexafluoride (SF6) gas will be used as a tamponade agent in all surgeries, and patients will be instructed to avoid the prone position for 5 days.
OCT images will be performed in the first 5 postoperative days and months 1, 3 and 6.
The primary outcome is anatomic closure of the MH closure in the month 6. The second outcomes are: mean best corrected visual acuity (BCVA) at month 6, mean change in the BCVA at month 6; integrity of the perifoveal external limiting membrane and ellipsoid zone on Optical Coherence Tomography (OCT); MH closure rate over time in days; functional improvement of microperimetry Statistical analysis will be performed with Student t-test and the p-value of ≤ 0.05 is considered significant.
- Conditions
- Macular Holes
- Being tested
- Conventional ILM Peeling, Inverted ILM Peeling
- 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.
Conventional ILM PeelingProcedure or surgery
peeling with complete removal of the internal limiting membrane (ILM)
Inverted ILM PeelingProcedure or surgery
the inverted ILM peeling technique - the technique of Inverted flap described by Michalewska, in which the ILM is left in the edge of the macular hole and the free area is inverted over the macular hole before fluid-air exchange
| Study group | Role | What they receive |
|---|---|---|
| Group A: Conventional ILM peeling | Active comparator | peeling with complete removal of the internal limiting membrane (ILM) Receives: Procedure: Conventional ILM Peeling |
| GroupB: Inverted ILM Peeling | Active comparator | the inverted ILM peeling technique, in which the ILM is left in the edge of the macular hole and the free area is inverted over the macular hole before fluid-air exchange Receives: Procedure: Inverted ILM Peeling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Anatomic closure
Rate of anatomic macular hole closure in the OCT at month 6
Measured: Month 6 post operative
Secondary outcomes (3)
BCVA mean
mean best corrected visual acuity (BCVA) at month 6
Measured: Month 6 post operative
BCVA change
change in the BCVA at month 6
Measured: Screening and Month 6 post operative
Integrity Membrane measured in microns (μm) by OCT
In the month 6, the area of discontinuity of the perifoveal external limiting membrane and ellipsoid zone in the OCT images will be measured in microns (μm) and correlated between groups
Measured: Month 6 post operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2019
- Study start15 Jun 2018
- Primary completion15 Jun 2020 (estimated)
- Study completion30 Jun 2020 (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.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- In Group A, patients will undergo peeling with complete removal of the internal limiting membrane (ILM) and in the group B, the inverted ILM peeling technique will be performed.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mauricio Maia, Federal University of São Paulo
- Investigators
- Mauricio Maia, MD, PhD, Study director, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03888625
- Sponsor's protocol ID
- IMH2019
- Status last verified
- Mar 2019
- First submitted
- 21 Mar 2019
- Last updated
- 25 Mar 2019
- 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 25 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trials to Compare the Healing Process of Idiopathic Macular Hole With Different Surgical Techniques
- ClinicalTrials.gov ID
- NCT03888625
- Acronym / sponsor ID
- IMH2019
- Conditions
- Macular Holes
- Keywords
- macular holes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Study start
- 15 Jun 2018 (actual)
- Primary completion
- 15 Jun 2020 (estimated)
- Study completion
- 30 Jun 2020 (estimated)
- First posted
- 25 Mar 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.
To compare anatomic and functional results, and to evaluate postoperatively the healing process in 2 different techniques for the closure of the macular holes (MH)
Detailed description
Patients with macular holes classified in stages 3 and 4 will be randomized into 2 groups. . In Group A, patients will undergo peeling with complete removal of the internal limiting membrane (ILM) and in the group B, the inverted ILM peeling technique will be performed. The 20% sulfur hexafluoride (SF6) gas will be used as a tamponade agent in all surgeries, and patients will be instructed to avoid the prone position for 5 days.
OCT images will be performed in the first 5 postoperative days and months 1, 3 and 6.
The primary outcome is anatomic closure of the MH closure in the month 6. The second outcomes are: mean best corrected visual acuity (BCVA) at month 6, mean change in the BCVA at month 6; integrity of the perifoveal external limiting membrane and ellipsoid zone on Optical Coherence Tomography (OCT); MH closure rate over time in days; functional improvement of microperimetry Statistical analysis will be performed with Student t-test and the p-value of ≤ 0.05 is considered significant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- In Group A, patients will undergo peeling with complete removal of the internal limiting membrane (ILM) and in the group B, the inverted ILM peeling technique will be performed.
| Arm | Type | Receives |
|---|---|---|
| Group A: Conventional ILM peeling | Active comparator | Procedure: Conventional ILM Peelingpeeling with complete removal of the internal limiting membrane (ILM) |
| GroupB: Inverted ILM Peeling | Active comparator | Procedure: Inverted ILM Peelingthe inverted ILM peeling technique, in which the ILM is left in the edge of the macular hole and the free area is inverted over the macular hole before fluid-air exchange |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- > Stage 3 and 4 macular holes with visual acuity between 20/30 and 20/800 according to the ETDRS chart.
Key exclusion criteria (7 listed)
- Macular holes secondary to ocular trauma, myopia or retinal detachment
- Any previous treatment for the macular hole
- Evidence on examination of any diabetic retinopathy
- History or presence of wet or dry age macular degeneration (AMD)
- Presence of epiretinal membrane or prior uveitis
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 |
|---|---|---|
| Conventional ILM Peelingpeeling with complete removal of the internal limiting membrane (ILM) | Procedure or surgery | Group A: Conventional ILM peeling |
| Inverted ILM Peelingthe inverted ILM peeling technique - the technique of Inverted flap described by Michalewska, in which the ILM is left in the edge of the macular hole and the free area is inverted over the macular hole before fluid-air exchange | Procedure or surgery | GroupB: Inverted ILM Peeling |
Primary outcome
Rate of Anatomic closure
Time frame: Month 6 post operative
Rate of anatomic macular hole closure in the OCT at month 6
3 secondary outcomes
BCVA mean
Time frame: Month 6 post operative
BCVA change
Time frame: Screening and Month 6 post operative
Integrity Membrane measured in microns (μm) by OCT
Time frame: Month 6 post operative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2019.
- 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.
Mauricio Maia, MD, PhD study director
Federal University of São Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional ILM Peeling and Inverted ILM Peeling in people with Macular Holes, run by Federal University of São Paulo at 1 site in Brazil.
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 7 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 25 Mar 2019. 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 Brazil. 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 Mauricio Maia, MD, PhD (+55-18-991137727, maiamauricio@terra.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Anatomic closure (time frame: Month 6 post operative). 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 25 Mar 2019.