Internal Limiting Membrane PeelingNCT04655781
Internal Limiting Membrane Peeling on Retinal Displacement
A study testing idiopathic macular hole (MH) surgery in people with Internal Limiting Membrane Peeling, run by The First Affiliated Hospital with Nanjing Medical University.
Trial summary
The purpose of this study is to investigate displacement of the retina after idiopathic macular hole surgery with different internal limiting membrane peeling patterns. Read more about this study
- Who is it for?
- Ages 10 to 80 years
- Conditions the study is for
- Internal Limiting Membrane Peeling
- What is being tested?
- idiopathic macular hole (MH) surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2017to 31 Jan 2018
- 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 10 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Eyes with idiopathic macular hole
Who cannot join
- Eyes having re-do macular hole surgery, with high myopia, with proliferative vitreoretinopathy or with a retinal detachment combined with the MH, with other macular diseases, such as age-related macular degeneration.
About this study
Official title: Displacement of the Retina After Idiopathic Macular Hole Surgery With Different Internal Limiting Membrane Peeling Patterns
The purpose of this study is to investigate displacement of the retina after idiopathic macular hole surgery with different internal limiting membrane peeling patterns.
Read the detailed description
After being informed about the study and potential risks, all patients giving written informed consent will undergo a 1-week screening period to determine eligibility for study entry. All patients with idiopathic MH will be randomly allocated into two groups, N-T group or T-N group.
- Conditions
- Internal Limiting Membrane Peeling
- Being tested
- idiopathic macular hole (MH) surgery
- Keywords
- Retinal displacement, Idiopathic macular hole, Internal limiting membrane peeling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
idiopathic macular hole (MH) surgeryProcedure or surgery
Idiopathic Macular Hole Surgery with Different Internal Limiting Membrane Peeling Patterns
| Study group | Role | What they receive |
|---|---|---|
| N-T group | Experimental | ILM was peeled off from nasal retina to temporal retina. Receives: Procedure: idiopathic macular hole (MH) surgery |
| T-N group | Experimental | ILM was peeled off from temporal retina to nasal retina Receives: Procedure: idiopathic macular hole (MH) surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
T-OD
measurement of temporal vessel to optic disc
Measured: preoperation to postoperative 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2020
- Study start1 Jan 2017
- Primary completion31 Jan 2018
- Study completion31 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Internal Limiting Membrane PeelingStudies 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04655781
- Sponsor's protocol ID
- ILM Peeling
- Status last verified
- Nov 2020
- First submitted
- 30 Nov 2020
- Last updated
- 7 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- 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 7 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Displacement of the Retina After Idiopathic Macular Hole Surgery With Different Internal Limiting Membrane Peeling Patterns
- ClinicalTrials.gov ID
- NCT04655781
- Acronym / sponsor ID
- ILM Peeling
- Conditions
- Internal Limiting Membrane Peeling
- Keywords
- Retinal displacement, Idiopathic macular hole, Internal limiting membrane peeling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 31 Jan 2018 (actual)
- Study completion
- 31 Jan 2018 (actual)
- First posted
- 7 Dec 2020 (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.
The purpose of this study is to investigate displacement of the retina after idiopathic macular hole surgery with different internal limiting membrane peeling patterns.
Detailed description
After being informed about the study and potential risks, all patients giving written informed consent will undergo a 1-week screening period to determine eligibility for study entry. All patients with idiopathic MH will be randomly allocated into two groups, N-T group or T-N group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| N-T group | Experimental | Procedure: idiopathic macular hole (MH) surgeryILM was peeled off from nasal retina to temporal retina. |
| T-N group | Experimental | Procedure: idiopathic macular hole (MH) surgeryILM was peeled off from temporal retina to nasal retina |
Who may qualify
- Ages
- 10 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Eyes with idiopathic macular hole
Key exclusion criteria (1 listed)
- Eyes having re-do macular hole surgery, with high myopia, with proliferative vitreoretinopathy or with a retinal detachment combined with the MH, with other macular diseases, such as age-related macular degeneration.
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 |
|---|---|---|
| idiopathic macular hole (MH) surgeryIdiopathic Macular Hole Surgery with Different Internal Limiting Membrane Peeling Patterns | Procedure or surgery | N-T group, T-N group |
Primary outcome
T-OD
Time frame: preoperation to postoperative 6 months
measurement of temporal vessel to optic disc
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing idiopathic macular hole (MH) surgery in people with Internal Limiting Membrane Peeling, run by The First Affiliated Hospital with Nanjing Medical University.
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: finished, as of the sponsor's last update on 7 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
T-OD (time frame: preoperation to postoperative 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 7 Dec 2020.