Macular HolesNCT04904679
The Use of Amniotic Membrane or Internal Limiting Membrane for Large or Refractory Macular Holes: A Prospective Study
A study testing Pars plana Vitrectomy with internal limiting membrane peeling in people with Macular Holes, run by Hospital Oftalmologico de Sorocaba at 2 sites in Brazil.
Trial summary
Prospective, randomized, unmasked interventional study. To evaluate anatomical and functional results through microperimetry in cases of refractory or large macular holes (MH), using amniotic membrane (AM) or internal limiting membrane ( ILM ). 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?
- Pars plana Vitrectomy with internal limiting membrane peeling
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 2 sitesBrazil
- Study dates
- 26 Jun 2020to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Patients with a macula hole that falls into the two categories below:
- Patients with idiopathic macular hole (with no history of secondary macular hole) ≥ 600 microns (measured using optical coherence tomography)
- Patients with an idiopathic macular hole submitted to conventional treatment without closing it (of any size).
- History of the disease less than 18 months
- Aged over 18 years old
- Visual acuity less than 20/32
Who cannot join
- History of any previous macular disease other than idiopathic macular hole
- Macular hole of other causes (secondary)
- Patients with diabetic retinopathy or other retinal vascular diseases
- Eyes subjected to intravitreal injection of any medication
- Visual acuity <20/400 of any retinal cause in the contralateral eye or absence of the globe *Aged under 50 years old
- Cataract and anti-glaucoma surgery less than 3 months before the study
Show all 12Show fewer
- Glaucoma with optic nerve excavation > 0.7 in the studied eye
- Intraocular pressure > 24 mmHg with the use of maximum medication in the studied eye
- History of vitreoretinal surgery for a condition other than the idiopathic macular hole (retinal detachment, vitreous hemorrhage)
- History of retinal detachment of any etiology
- A patient who manifests himself not being able to perform the head position in the postoperative period
- A patient with active anterior or posterior uveitis
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites
Hospital Oftalmologico de Sorocaba/ Banco de Olhos de Sorocaba
Sorocaba, São Paulo, 18031060
Sorocaba Eye's Hospital
Sorocaba, São Paulo, 18031060
About this study
Official title: The Use of Amniotic Membrane or Inverted Internal Limiting Membrane Flap for Large or Refractory Macular Holes: a Prospective, Comparative Study Using Microperimetry
Prospective, randomized, unmasked interventional study. To evaluate anatomical and functional results through microperimetry in cases of refractory or large macular holes (MH), using amniotic membrane (AM) or internal limiting membrane ( ILM ).
Read the detailed description
This study will evaluate functional outcomes through microperimetry in patients undergoing macular hole surgery. It will focus on patients with macular holes ≥600 microns, as well as those with holes refractory to conventional surgical treatment. The study will assess the use of amniotic membrane or internal limiting membrane (ILM) as adjuncts in the macular hole closure process.
The gold-standard treatment for idiopathic macular holes is pars plana vitrectomy (PPV), which involves removal of the posterior hyaloid (when adhered) and the ILM using a vital dye, followed by placement of buffering gas (C3F8 or SF6) at a non-expandable concentration. However, approximately 44% of large macular holes remain unclosed after conventional surgery.
To improve closure rates in such cases, new techniques have been introduced, including the inverted ILM flap technique and the free ILM flap technique. While studies demonstrate the effectiveness of these techniques, they show no significant improvement in visual function.
The amniotic membrane (AM) has recently been explored as an adjunct for macular hole closure and as a substrate for cell growth and visual acuity improvement. Amniotic membranes are believed to promote epithelialization and possess anti-fibrotic, anti-inflammatory, anti-angiogenic, and antimicrobial properties.
In this study, eligible patients will be randomized into two groups:
- Group 1: Undergoing PPV with ILM removal, followed by placement of an amniotic membrane plug inside the macular hole, with its chorionic face in contact with the retinal pigment epithelium (RPE).
- Group 2: Undergoing PPV with ILM removal, followed by placement of either an inverted ILM flap or a free ILM fragment for refractory cases, positioned over (inverted flap) or inside (free flap) the macular hole.
Once the AM plug or ILM flap is confirmed in its correct location, a fluid-gas exchange will be performed with 12.5% C3F8 buffering gas, and patients will maintain a face-down position for 7 days postoperatively.
Patients included in the study will undergo:
- Preoperative assessment, including best-corrected visual acuity (BCVA) measurement, optical coherence tomography (OCT) using the Zeiss Cirrus 5000, and microperimetry using the Macular Integrity Assessment (MAIA) device.
- Postoperative evaluations at day 1 and day 7, followed by assessments at 1, 3, 6, and 12 months. During these visits:- A complete ophthalmic examination will be performed.
- OCT imaging will be conducted at day 7, month 1, month 3, month 6, and month 12.
- Microperimetry will be conducted at months 1, 3, 6, and 12 to evaluate anatomical and functional responses.
The use of the amniotic membrane, given its anti-inflammatory, anti-fibrotic, and cell growth-supporting properties, is expected to increase closure rates in refractory and large macular holes and contribute to better functional outcomes by supporting outer retinal layer regeneration.
The Sorocaba Eye Bank (BOS) will provide, prepare, and preserve the amniotic membrane used in this study.
- Conditions
- Macular Holes
- Being tested
- Pars plana Vitrectomy with internal limiting membrane peeling
- Keywords
- Human Amniotic Membranes in macular holes using microperimetry
- Medical subject headings
- Retinal Perforations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pars plana Vitrectomy with internal limiting membrane peelingDevice
Also called Use of Amniotic membrane plug, Use of a internal limiting membrane inverted flap, gas tamponade (C3F8 12,5%)
The pars plana 23-gauge (23G) vitrectomy technique will be performed with removal of the internal limiting membrane (ILM) (when adhered to the macula) and placement of either an amniotic membrane plug or an ILM flap in the macular hole. This will be followed by a fluid-air exchange and buffering gas infusion (12.5% C3F8).
The amniotic membrane plug will be prepared using a dermatological punch with a diameter of 1 to 2 mm, depending on the size of the macular hole as measured by OCT. It will be positioned inside the macular hole using 23G forceps, with its chorionic side facing the retinal pigmented epithelium (RPE).
The ILM flap will be created at the time of peeling-with an inverted flap in primary cases and a free flap in refractory cases. It will be positioned over the hole (inverted flap) or inside the macular hole (free flap) using 23G ILM forceps.
These techniques will be assisted by the use of an extra lighting sclerotomy.
| Study group | Role | What they receive |
|---|---|---|
| Amniotic Membrane group | Active comparator | Patients who will be treated with a amniotic membrane plug Receives: Device: Pars plana Vitrectomy with internal limiting membrane peeling |
| Internal Limiting Membrane group | Active comparator | patients who will be treated with a internal limiting membrane flap Receives: Device: Pars plana Vitrectomy with internal limiting membrane peeling |
What is being measured
The primary outcome is the main question the study is designed to answer.
The retinal sensitivity
measured by the microperimetry
Measured: through study completion, an average of 1 year
The fixation stability
measured by the microperimetry
Measured: through study completion, an average of 1 year
Secondary outcomes (1)
the macula hole closure rate
measured by OCT
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2021
- Study start26 Jun 2020
- Primary completion30 Sep 2023
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- 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
- Prospective, randomized, unmasked single center interventional study
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Oftalmologico de Sorocaba
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anna Carolina Carvalho Araujo, Hospital Oftalmologico de Sorocaba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04904679
- Sponsor's protocol ID
- HAMprotocol
- Status last verified
- May 2025
- First submitted
- 17 May 2021
- Last updated
- 6 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Only the microperimetry graphs and OCT images will be published, without any IPD.
Publications
Jirsova K, Jones GLA. Amniotic membrane in ophthalmology: properties, preparation, storage and indications for grafting-a review. Cell Tissue Bank. 2017 Jun;18(2):193-204. doi: 10.1007/s10561-017-9618-5. Epub 2017 Mar 2.
PubMed 28255771Ferreira MA, Maia A, Machado AJ, Ferreira REA, Hagemann LF, Junior PHER, Rezende FA. Human amniotic membrane for the treatment of large and refractory macular holes: a retrospective, multicentric, interventional study. Int J Retina Vitreous. 2021 May 8;7(1):38. doi: 10.1186/s40942-021-00308-6.
PubMed 33964971Caporossi T, Tartaro R, De Angelis L, Pacini B, Rizzo S. A human amniotic membrane plug to repair retinal detachment associated with large macular tear. Acta Ophthalmol. 2019 Dec;97(8):821-823. doi: 10.1111/aos.14109. Epub 2019 Apr 6.
PubMed 30953398Rizzo S, Caporossi T, Tartaro R, Finocchio L, Franco F, Barca F, Giansanti F. A Human Amniotic Membrane Plug to Promote Retinal Breaks Repair and Recurrent Macular Hole Closure. Retina. 2019 Oct;39 Suppl 1:S95-S103. doi: 10.1097/IAE.0000000000002320. No abstract available.
PubMed 30312261Caporossi T, Pacini B, De Angelis L, Barca F, Peiretti E, Rizzo S. HUMAN AMNIOTIC MEMBRANE TO CLOSE RECURRENT, HIGH MYOPIC MACULAR HOLES IN PATHOLOGIC MYOPIA WITH AXIAL LENGTH OF >/=30 mm. Retina. 2020 Oct;40(10):1946-1954. doi: 10.1097/IAE.0000000000002699.
PubMed 31868775Meyer CH, Borny R, Horchi N. Subretinal fluid application to close a refractory full thickness macular hole. Int J Retina Vitreous. 2017 Nov 27;3:44. doi: 10.1186/s40942-017-0094-7. eCollection 2017.
PubMed 29209516Kase S, Saito W, Mori S, Saito M, Ando R, Dong Z, Suzuki T, Noda K, Ishida S. Clinical and histological evaluation of large macular hole surgery using the inverted internal limiting membrane flap technique. Clin Ophthalmol. 2016 Dec 16;11:9-14. doi: 10.2147/OPTH.S119762. eCollection 2017.
PubMed 28031697Ch'ng SW, Patton N, Ahmed M, Ivanova T, Baumann C, Charles S, Jalil A. The Manchester Large Macular Hole Study: Is it Time to Reclassify Large Macular Holes? Am J Ophthalmol. 2018 Nov;195:36-42. doi: 10.1016/j.ajo.2018.07.027. Epub 2018 Jul 30.
PubMed 30071212Passemard M, Yakoubi Y, Muselier A, Hubert I, Guillaubey A, Bron AM, Berrod JP, Creuzot-Garcher C. Long-term outcome of idiopathic macular hole surgery. Am J Ophthalmol. 2010 Jan;149(1):120-6. doi: 10.1016/j.ajo.2009.08.003. Epub 2009 Oct 20.
PubMed 19846059Lois N, Burr J, Norrie J, Vale L, Cook J, McDonald A, Boachie C, Ternent L, McPherson G; Full-thickness Macular Hole and Internal Limiting Membrane Peeling Study (FILMS) Group. Internal limiting membrane peeling versus no peeling for idiopathic full-thickness macular hole: a pragmatic randomized controlled trial. Invest Ophthalmol Vis Sci. 2011 Mar 1;52(3):1586-92. doi: 10.1167/iovs.10-6287.
PubMed 21051731Carvalho Araujo AC, Bordon AF, Falcao V, Bortolai P, Dib E, Maia M. The use of amniotic membrane or inverted internal limiting membrane flap for large or refractory macular holes: a prospective, comparative study using microperimetry. Graefes Arch Clin Exp Ophthalmol. 2025 Dec;263(12):3347-3363. doi: 10.1007/s00417-025-06917-3. Epub 2025 Sep 15.
PubMed 40952489
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Amniotic Membrane or Inverted Internal Limiting Membrane Flap for Large or Refractory Macular Holes: a Prospective, Comparative Study Using Microperimetry
- ClinicalTrials.gov ID
- NCT04904679
- Acronym / sponsor ID
- HAMprotocol
- Conditions
- Macular Holes
- Keywords
- Human Amniotic Membranes in macular holes using microperimetry
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Hospital Oftalmologico de SorocabaUniversity, hospital or other
- Study start
- 26 Jun 2020 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 27 May 2021 (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.
Prospective, randomized, unmasked interventional study. To evaluate anatomical and functional results through microperimetry in cases of refractory or large macular holes (MH), using amniotic membrane (AM) or internal limiting membrane ( ILM ).
Detailed description
This study will evaluate functional outcomes through microperimetry in patients undergoing macular hole surgery. It will focus on patients with macular holes ≥600 microns, as well as those with holes refractory to conventional surgical treatment. The study will assess the use of amniotic membrane or internal limiting membrane (ILM) as adjuncts in the macular hole closure process.
The gold-standard treatment for idiopathic macular holes is pars plana vitrectomy (PPV), which involves removal of the posterior hyaloid (when adhered) and the ILM using a vital dye, followed by placement of buffering gas (C3F8 or SF6) at a non-expandable concentration. However, approximately 44% of large macular holes remain unclosed after conventional surgery.
To improve closure rates in such cases, new techniques have been introduced, including the inverted ILM flap technique and the free ILM flap technique. While studies demonstrate the effectiveness of these techniques, they show no significant improvement in visual function.
The amniotic membrane (AM) has recently been explored as an adjunct for macular hole closure and as a substrate for cell growth and visual acuity improvement. Amniotic membranes are believed to promote epithelialization and possess anti-fibrotic, anti-inflammatory, anti-angiogenic, and antimicrobial properties.
In this study, eligible patients will be randomized into two groups:
- Group 1: Undergoing PPV with ILM removal, followed by placement of an amniotic membrane plug inside the macular hole, with its chorionic face in contact with the retinal pigment epithelium (RPE).
- Group 2: Undergoing PPV with ILM removal, followed by placement of either an inverted ILM flap or a free ILM fragment for refractory cases, positioned over (inverted flap) or inside (free flap) the macular hole.
Once the AM plug or ILM flap is confirmed in its correct location, a fluid-gas exchange will be performed with 12.5% C3F8 buffering gas, and patients will maintain a face-down position for 7 days postoperatively.
Patients included in the study will undergo:
- Preoperative assessment, including best-corrected visual acuity (BCVA) measurement, optical coherence tomography (OCT) using the Zeiss Cirrus 5000, and microperimetry using the Macular Integrity Assessment (MAIA) device.
- Postoperative evaluations at day 1 and day 7, followed by assessments at 1, 3, 6, and 12 months. During these visits:- A complete ophthalmic examination will be performed.
- OCT imaging will be conducted at day 7, month 1, month 3, month 6, and month 12.
- Microperimetry will be conducted at months 1, 3, 6, and 12 to evaluate anatomical and functional responses.
The use of the amniotic membrane, given its anti-inflammatory, anti-fibrotic, and cell growth-supporting properties, is expected to increase closure rates in refractory and large macular holes and contribute to better functional outcomes by supporting outer retinal layer regeneration.
The Sorocaba Eye Bank (BOS) will provide, prepare, and preserve the amniotic membrane used in this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective, randomized, unmasked single center interventional study
| Arm | Type | Receives |
|---|---|---|
| Amniotic Membrane group | Active comparator | Device: Pars plana Vitrectomy with internal limiting membrane peelingPatients who will be treated with a amniotic membrane plug |
| Internal Limiting Membrane group | Active comparator | Device: Pars plana Vitrectomy with internal limiting membrane peelingpatients who will be treated with a internal limiting membrane flap |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with a macula hole that falls into the two categories below:
- Patients with idiopathic macular hole (with no history of secondary macular hole) ≥ 600 microns (measured using optical coherence tomography)
- Patients with an idiopathic macular hole submitted to conventional treatment without closing it (of any size).
- History of the disease less than 18 months
- Aged over 18 years old
Key exclusion criteria (12 listed)
- History of any previous macular disease other than idiopathic macular hole
- Macular hole of other causes (secondary)
- Patients with diabetic retinopathy or other retinal vascular diseases
- Eyes subjected to intravitreal injection of any medication
- Visual acuity <20/400 of any retinal cause in the contralateral eye or absence of the globe *Aged under 50 years old
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 |
|---|---|---|
| Pars plana Vitrectomy with internal limiting membrane peelingAlso: Use of Amniotic membrane plug, Use of a internal limiting membrane inverted flap, gas tamponade (C3F8 12,5%)The pars plana 23-gauge (23G) vitrectomy technique will be performed with removal of the internal limiting membrane (ILM) (when adhered to the macula) and placement of either an amniotic membrane plug or an ILM flap in the macular hole. This will be followed by a fluid-air exchange and buffering gas infusion (12.5% C3F8). The amniotic membrane plug will be prepared using a dermatological punch with a diameter of 1 to 2 mm, depending on the size of the macular hole as measured by OCT. It will be positioned inside the macular hole using 23G forceps, with its chorionic side facing the retinal pigmented epithelium (RPE). The ILM flap will be created at the time of peeling-with an inverted flap in primary cases and a free flap in refractory cases. It will be positioned over the hole (inverted flap) or inside the macular hole (free flap) using 23G ILM forceps. These techniques will be assisted by the use of an extra lighting sclerotomy. | Device | Amniotic Membrane group, Internal Limiting Membrane group |
Primary outcome
The retinal sensitivity
Time frame: through study completion, an average of 1 year
measured by the microperimetry
The fixation stability
Time frame: through study completion, an average of 1 year
measured by the microperimetry
1 secondary outcome
the macula hole closure rate
Time frame: through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2025.
- Results publication: PubMed 28255771Jirsova K, Jones GLA. Amniotic membrane in ophthalmology: properties, preparation, storage and indications for grafting-a review. Cell Tissue Bank. 2017 Jun;18(2):193-204. doi: 10.1007/s10561-017-9618-5. Epub 2017 Mar 2.
- Results publication: PubMed 33964971Ferreira MA, Maia A, Machado AJ, Ferreira REA, Hagemann LF, Junior PHER, Rezende FA. Human amniotic membrane for the treatment of large and refractory macular holes: a retrospective, multicentric, interventional study. Int J Retina Vitreous. 2021 May 8;7(1):38. doi: 10.1186/s40942-021-00308-6.
- Results publication: PubMed 30953398Caporossi T, Tartaro R, De Angelis L, Pacini B, Rizzo S. A human amniotic membrane plug to repair retinal detachment associated with large macular tear. Acta Ophthalmol. 2019 Dec;97(8):821-823. doi: 10.1111/aos.14109. Epub 2019 Apr 6.
- Results publication: PubMed 30312261Rizzo S, Caporossi T, Tartaro R, Finocchio L, Franco F, Barca F, Giansanti F. A Human Amniotic Membrane Plug to Promote Retinal Breaks Repair and Recurrent Macular Hole Closure. Retina. 2019 Oct;39 Suppl 1:S95-S103. doi: 10.1097/IAE.0000000000002320. No abstract available.
- Results publication: PubMed 31868775Caporossi T, Pacini B, De Angelis L, Barca F, Peiretti E, Rizzo S. HUMAN AMNIOTIC MEMBRANE TO CLOSE RECURRENT, HIGH MYOPIC MACULAR HOLES IN PATHOLOGIC MYOPIA WITH AXIAL LENGTH OF >/=30 mm. Retina. 2020 Oct;40(10):1946-1954. doi: 10.1097/IAE.0000000000002699.
- Results publication: PubMed 29209516Meyer CH, Borny R, Horchi N. Subretinal fluid application to close a refractory full thickness macular hole. Int J Retina Vitreous. 2017 Nov 27;3:44. doi: 10.1186/s40942-017-0094-7. eCollection 2017.
- Results publication: PubMed 28031697Kase S, Saito W, Mori S, Saito M, Ando R, Dong Z, Suzuki T, Noda K, Ishida S. Clinical and histological evaluation of large macular hole surgery using the inverted internal limiting membrane flap technique. Clin Ophthalmol. 2016 Dec 16;11:9-14. doi: 10.2147/OPTH.S119762. eCollection 2017.
- Results publication: PubMed 30071212Ch'ng SW, Patton N, Ahmed M, Ivanova T, Baumann C, Charles S, Jalil A. The Manchester Large Macular Hole Study: Is it Time to Reclassify Large Macular Holes? Am J Ophthalmol. 2018 Nov;195:36-42. doi: 10.1016/j.ajo.2018.07.027. Epub 2018 Jul 30.
- Results publication: PubMed 19846059Passemard M, Yakoubi Y, Muselier A, Hubert I, Guillaubey A, Bron AM, Berrod JP, Creuzot-Garcher C. Long-term outcome of idiopathic macular hole surgery. Am J Ophthalmol. 2010 Jan;149(1):120-6. doi: 10.1016/j.ajo.2009.08.003. Epub 2009 Oct 20.
- Results publication: PubMed 21051731Lois N, Burr J, Norrie J, Vale L, Cook J, McDonald A, Boachie C, Ternent L, McPherson G; Full-thickness Macular Hole and Internal Limiting Membrane Peeling Study (FILMS) Group. Internal limiting membrane peeling versus no peeling for idiopathic full-thickness macular hole: a pragmatic randomized controlled trial. Invest Ophthalmol Vis Sci. 2011 Mar 1;52(3):1586-92. doi: 10.1167/iovs.10-6287.
- Derived from this study: PubMed 40952489Carvalho Araujo AC, Bordon AF, Falcao V, Bortolai P, Dib E, Maia M. The use of amniotic membrane or inverted internal limiting membrane flap for large or refractory macular holes: a prospective, comparative study using microperimetry. Graefes Arch Clin Exp Ophthalmol. 2025 Dec;263(12):3347-3363. doi: 10.1007/s00417-025-06917-3. Epub 2025 Sep 15.
- Individual participant dataSharing planned: No. Only the microperimetry graphs and OCT images will be published, without any IPD.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pars plana Vitrectomy with internal limiting membrane peeling in people with Macular Holes, run by Hospital Oftalmologico de Sorocaba at 2 sites 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 6 inclusion and 12 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: under way, not looking for participants, as of the sponsor's last update on 6 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
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?
The retinal sensitivity (time frame: through study completion, an average of 1 year). The study lists 2 primary outcomes in all. 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 NCT04904679, which also lists 11 linked publications.
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 6 May 2025.