Macular HolesNCT05083650
Large Macular Hole Closure Rate With Amniotic Membrane Graft With and Without Limitorrhexis
A study testing Macular hole closure with amniotic membrane with/without internal limiting membrane peeling in people with Macular Holes, run by Instituto de Oftalmología Fundación Conde de Valenciana at 1 site in Mexico.
Trial summary
Patients with idiopathic macular holes (MHs) postoperative closure rates for large MHs (diameter > 550 μm) are disappointing and often require a second intervention, different techniques have been described with very variable success rates in different published studies, an efficient technique with good functional… Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- Macular Holes
- What is being tested?
- Macular hole closure with amniotic membrane with/without internal limiting membrane peeling
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteMexico
- Study dates
- 10 Mar 2021to 10 Mar 2023
- 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 40 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Not myopic patients (<6 Dioptre or <26 mm)
- Large macular hole >550 μm
- > 6 months symptoms
- Signing informed consent
Who cannot join
- Patients with other ocular disease (diabetic retinopathy, glaucoma, uveitis, ocular tumors, etc)
- Using systemic drugs that are toxic for the optic nerve or retina (chloroquine, hydroxychloroquine, tamoxifen, ethambutol, etc)
- Patients with ocular surgery
Trial locations and contacts
1 site in 1 country.
Mexico1 site, 1 recruiting
- Recruiting
Instituto de Oftalmologia Conde de Valenciana
Mexico City, 06800
Jose Luis Rodriguez Loaiza, MD, +52 5554123012, jose.rodriguez@institutodeoftalmologia.org
About this study
Official title: Comparison of Macular Hole Closure Rate in Patients With Poor Prognosis Clinical Features Treated With Amniotic Membrane Graft With and Without Limitorrhexis
Patients with idiopathic macular holes (MHs) postoperative closure rates for large MHs (diameter > 550 μm) are disappointing and often require a second intervention, different techniques have been described with very variable success rates in different published studies, an efficient technique with good functional outcome has not been found.
Read the detailed description
Interventional study in large macular holes (diameter > 550 μm) using an amniotic membrane with and without internal limiting membrane peeling.
- Conditions
- Macular Holes
- Being tested
- Macular hole closure with amniotic membrane with/without internal limiting membrane peeling
- Medical subject headings
- Retinal Perforations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Macular hole closure with amniotic membrane with/without internal limiting membrane peelingProcedure or surgery
Pars plana vitrectomy with/without internal limiting membrane peeling, amniotic membrane, and air tamponade
| Study group | Role | What they receive |
|---|---|---|
| Amniotic membrane without internal limiting membrane peeling | Experimental | The surgery performed will be phacoemulsification + vitrectomy using an amniotic membrane to plug the macular hole using air as tamponade. Receives: Procedure: Macular hole closure with amniotic membrane with/without internal limiting membrane peeling |
| Amniotic membrane with internal limiting membrane peeling | Active comparator | The surgery performed will be phacoemulsification + vitrectomy + internal limiting membrane peeling using an amniotic membrane to plug the macular hole using air as tamponade. Receives: Procedure: Macular hole closure with amniotic membrane with/without internal limiting membrane peeling |
What is being measured
The primary outcome is the main question the study is designed to answer.
% of macular hole clousure measured with OCT
Closure of the macular hole by optical coherence tomography
Measured: 6 months
Secondary outcomes (2)
Best-corrected visual acuity measured with Snellen Chart
Improvement of 2 lines in best-corrected visual acuity
Measured: 6 months
Superficial and deep retinal capillary plexus density with OCT-A
Presence of capillary plexus in macular hole area
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2021
- Study start10 Mar 2021
- Primary completion10 Dec 2022 (estimated)
- Study completion10 Mar 2023 (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
- Sequential
- Model description
- Large MHs (diameter \> 550 μm)
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto de Oftalmología Fundación Conde de Valenciana
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jose Luis Rodriguez Loaiza, Instituto de Oftalmología Fundación Conde de Valenciana
- Investigators
- Daniel Rios Esquer, MD, Principal investigator, Instituto de Oftalmologia Conde de ValencianaIshtar A Astorga Carballo, MD, Principal investigator, Instituto de Oftalmologia Conde de ValencianaJose L Rodriguez Loaiza, MD, Principal investigator, Instituto de Oftalmologia Conde de ValencianaZita Chao Loyo, MD, Principal investigator, Instituto de Oftalmologia Conde de ValencianaFelipe Esparza Correa, MD, Principal investigator, Instituto de Oftalmologia Conde de Valenciana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05083650
- Sponsor's protocol ID
- MAM CONDE
- Status last verified
- Oct 2021
- First submitted
- 25 Jun 2019
- Last updated
- 19 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Macular Hole Closure Rate in Patients With Poor Prognosis Clinical Features Treated With Amniotic Membrane Graft With and Without Limitorrhexis
- ClinicalTrials.gov ID
- NCT05083650
- Acronym / sponsor ID
- MAM CONDE
- Conditions
- Macular Holes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Instituto de Oftalmología Fundación Conde de ValencianaUniversity, hospital or other
- Study start
- 10 Mar 2021 (actual)
- Primary completion
- 10 Dec 2022 (estimated)
- Study completion
- 10 Mar 2023 (estimated)
- First posted
- 19 Oct 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.
Patients with idiopathic macular holes (MHs) postoperative closure rates for large MHs (diameter > 550 μm) are disappointing and often require a second intervention, different techniques have been described with very variable success rates in different published studies, an efficient technique with good functional outcome has not been found.
Detailed description
Interventional study in large macular holes (diameter > 550 μm) using an amniotic membrane with and without internal limiting membrane peeling.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Large MHs (diameter > 550 μm)
| Arm | Type | Receives |
|---|---|---|
| Amniotic membrane without internal limiting membrane peeling | Experimental | Procedure: Macular hole closure with amniotic membrane with/without internal limiting membrane peelingThe surgery performed will be phacoemulsification + vitrectomy using an amniotic membrane to plug the macular hole using air as tamponade. |
| Amniotic membrane with internal limiting membrane peeling | Active comparator | Procedure: Macular hole closure with amniotic membrane with/without internal limiting membrane peelingThe surgery performed will be phacoemulsification + vitrectomy + internal limiting membrane peeling using an amniotic membrane to plug the macular hole using air as tamponade. |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Not myopic patients (<6 Dioptre or <26 mm)
- Large macular hole >550 μm
- > 6 months symptoms
- Signing informed consent
Key exclusion criteria (3 listed)
- Patients with other ocular disease (diabetic retinopathy, glaucoma, uveitis, ocular tumors, etc)
- Using systemic drugs that are toxic for the optic nerve or retina (chloroquine, hydroxychloroquine, tamoxifen, ethambutol, etc)
- Patients with 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 |
|---|---|---|
| Macular hole closure with amniotic membrane with/without internal limiting membrane peelingPars plana vitrectomy with/without internal limiting membrane peeling, amniotic membrane, and air tamponade | Procedure or surgery | Amniotic membrane with internal limiting membrane peeling, Amniotic membrane without internal limiting membrane peeling |
Primary outcome
% of macular hole clousure measured with OCT
Time frame: 6 months
Closure of the macular hole by optical coherence tomography
2 secondary outcomes
Best-corrected visual acuity measured with Snellen Chart
Time frame: 6 months
Superficial and deep retinal capillary plexus density with OCT-A
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2021.
- Individual participant dataSharing planned: Undecided
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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.
Daniel Rios Esquer, MD principal investigator
Instituto de Oftalmologia Conde de Valenciana
Ishtar A Astorga Carballo, MD principal investigator
Instituto de Oftalmologia Conde de Valenciana
Jose L Rodriguez Loaiza, MD principal investigator
Instituto de Oftalmologia Conde de Valenciana
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Macular hole closure with amniotic membrane with/without internal limiting membrane peeling in people with Macular Holes, run by Instituto de Oftalmología Fundación Conde de Valenciana at 1 site in Mexico.
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 4 inclusion and 3 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 19 Oct 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 Mexico. 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 Zita Chao Loyo, MD (+52 33994182, investigacionretinaconval@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
% of macular hole clousure measured with OCT (time frame: 6 months). 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 19 Oct 2021.