Idiopathic Macular HoleNCT05757349
Analysis of Novel Positioning Sensor-assisted Postoperative Position Correction and Effective Prone Time Recorded in Patients With Different Prone Times After Macular Hole Surgery
A study testing Face-down position time 1-day and Face-down position time 3-day in people with Idiopathic Macular Hole and Effective Prone Time, run by Tianjin Medical University Eye Hospital at 1 site in China.
Trial summary
Idiopathic macular hole (IMH) is a fundus disease without clear etiology, most often seen in healthy women over 50 years of age, and is often associated with ocular manifestations such as loss of central vision and visual distortion. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Idiopathic Macular Hole, Effective Prone Time
- What is being tested?
- Face-down position time 1-day and Face-down position time 3-day
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2022to 30 Mar 2024
- 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
- Patients aged 18 years or older；
- Patients diagnosed with IMH;
- Patients requiring face-down position after vitrectomy combined with ILM peeling and C3F8(14%) gas filling; Tolerated face-down position after surgery;
- Agreed to the study protocol.
Who cannot join
- Myopia greater than or equal to -6.0 D; Eye axis length (AL) greater than 26.0mm;
- Trauma, macular edema, macular degeneration, and other secondary MH with clear etiology;
- Previous history of internal eye surgery in the operated eye;
- Patients with local or systemic other diseases significantly affecting visual function;
- Those who cannot maintain face-down position after surgery due to systemic factors, etc.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tianjin medical university eye hosipital
Tianjin, Tianjin Municipality
Bojie Hu, 13612130943, bhu07@tmu.edu.cn
About this study
Official title: A Prospective Study on the Prognosis of the Idiopathic Macular Hole With Different Prone Position Times Assisted by Novel Positioning Sensor
Idiopathic macular hole (IMH) is a fundus disease without clear etiology, most often seen in healthy women over 50 years of age, and is often associated with ocular manifestations such as loss of central vision and visual distortion. It is often associated with loss of central vision, visual distortion, and other ocular manifestations. It is currently treated by vitrectomy combined with internal limiting membranes (ILM) peeling followed by gas filling. A strict prone position for a certain period of time after surgery has a positive effect on the healing of the macular fissure. The need for a strict prone position after IMH has been demonstrated in previous studies (especially when the IMH diameter is >400 μm). However, due to the anti-human mechanics of the face-down position, patient comfort, sleep quality and quality of life are greatly compromised. Therefore, this study designed a smart head position monitoring device to assist patients in maintaining the correct position and recording the effective position time. The study was conducted to determine the shortest prone position time based on macular fissure closure, to minimize the adverse effects of postoperative position, and to obtain the maximum recovery of visual acuity and visual field.
- Conditions
- Idiopathic Macular Hole, Effective Prone Time
- Being tested
- Face-down position time 1-day, Face-down position time 3-day
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Face-down position time 1-dayBehavioural
Postoperative face-down position of subjects wearing the novel positioning sensor device for 1-day.
Face-down position time 3-dayBehavioural
Postoperative face-down position of subjects wearing the novel positioning sensor device for 3-day.
| Study group | Role | What they receive |
|---|---|---|
| Face-down position time 1-day group | Experimental | Postoperative face-down position of subjects wearing the novel positioning sensor device for 1-day. Receives: Behavioral: Face-down position time 1-day |
| Face-down position time 3-day group | Active comparator | Postoperative face-down position of subjects wearing the novel positioning sensor device for 3-day. Receives: Behavioral: Face-down position time 3-day |
What is being measured
The primary outcome is the main question the study is designed to answer.
Macular hole closure rate
Ratio of patients with postoperative lacunae that remained closed until the end of the follow-up time to the number of patients who reopened during the follow-up time of those who did not close after surgery
Measured: 6 month postoperatively
Effective face-down position time
Novel positioning sensor related data cloud storage platform can record and extract effective face-down position time.
Measured: 1 or 3 day postoperatively
Secondary outcomes (5)
Best corrected visual acuity change (BCVA)
BCVA for patients after macular fissure surgery, expressed using the (ETDRS) Alphabet Chart.
Measured: 1, 3, 6 month postoperatively
Retinal nerve fiber layer thickness change
Three-dimensional spectral domain optical coherence tomography (SD-OCT)
Measured: 1, 3, 6 month postoperatively
Macular ganglion cell complex thickness change (GCL+, GCL++)
Three-dimensional spectral domain optical coherence tomography (SD-OCT)
Measured: 1, 3, 6 month postoperatively
Mean retinal Sensitivity (MS)
Micro Perimeter 3
Measured: 1, 3, 6 month postoperatively
Central 2˚ and 4˚ fixation
Micro Perimeter 3
Measured: 1, 3, 6 month postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2023
- Study start1 Oct 2022
- Primary completion30 Mar 2024 (estimated)
- Study completion30 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Macular HoleStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tianjin Medical University Eye Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bojie Hu, Tianjin Medical University Eye Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05757349
- Sponsor's protocol ID
- TianjinMUEHhbj456
- Status last verified
- Feb 2023
- First submitted
- 14 Feb 2023
- Last updated
- 7 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study on the Prognosis of the Idiopathic Macular Hole With Different Prone Position Times Assisted by Novel Positioning Sensor
- ClinicalTrials.gov ID
- NCT05757349
- Acronym / sponsor ID
- TianjinMUEHhbj456
- Conditions
- Idiopathic Macular Hole, Effective Prone Time
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- Tianjin Medical University Eye HospitalUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 30 Mar 2024 (estimated)
- Study completion
- 30 Mar 2024 (estimated)
- First posted
- 7 Mar 2023 (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.
Idiopathic macular hole (IMH) is a fundus disease without clear etiology, most often seen in healthy women over 50 years of age, and is often associated with ocular manifestations such as loss of central vision and visual distortion. It is often associated with loss of central vision, visual distortion, and other ocular manifestations. It is currently treated by vitrectomy combined with internal limiting membranes (ILM) peeling followed by gas filling. A strict prone position for a certain period of time after surgery has a positive effect on the healing of the macular fissure. The need for a strict prone position after IMH has been demonstrated in previous studies (especially when the IMH diameter is >400 μm). However, due to the anti-human mechanics of the face-down position, patient comfort, sleep quality and quality of life are greatly compromised. Therefore, this study designed a smart head position monitoring device to assist patients in maintaining the correct position and recording the effective position time. The study was conducted to determine the shortest prone position time based on macular fissure closure, to minimize the adverse effects of postoperative position, and to obtain the maximum recovery of visual acuity and visual field.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Face-down position time 1-day group | Experimental | Behavioral: Face-down position time 1-dayPostoperative face-down position of subjects wearing the novel positioning sensor device for 1-day. |
| Face-down position time 3-day group | Active comparator | Behavioral: Face-down position time 3-dayPostoperative face-down position of subjects wearing the novel positioning sensor device for 3-day. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients aged 18 years or older；
- Patients diagnosed with IMH;
- Patients requiring face-down position after vitrectomy combined with ILM peeling and C3F8(14%) gas filling; Tolerated face-down position after surgery;
- Agreed to the study protocol.
Key exclusion criteria (5 listed)
- Myopia greater than or equal to -6.0 D; Eye axis length (AL) greater than 26.0mm;
- Trauma, macular edema, macular degeneration, and other secondary MH with clear etiology;
- Previous history of internal eye surgery in the operated eye;
- Patients with local or systemic other diseases significantly affecting visual function;
- Those who cannot maintain face-down position after surgery due to systemic factors, etc.
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 |
|---|---|---|
| Face-down position time 1-dayPostoperative face-down position of subjects wearing the novel positioning sensor device for 1-day. | Behavioural | Face-down position time 1-day group |
| Face-down position time 3-dayPostoperative face-down position of subjects wearing the novel positioning sensor device for 3-day. | Behavioural | Face-down position time 3-day group |
Primary outcome
Macular hole closure rate
Time frame: 6 month postoperatively
Ratio of patients with postoperative lacunae that remained closed until the end of the follow-up time to the number of patients who reopened during the follow-up time of those who did not close after surgery
Effective face-down position time
Time frame: 1 or 3 day postoperatively
Novel positioning sensor related data cloud storage platform can record and extract effective face-down position time.
5 secondary outcomes
Best corrected visual acuity change (BCVA)
Time frame: 1, 3, 6 month postoperatively
Retinal nerve fiber layer thickness change
Time frame: 1, 3, 6 month postoperatively
Macular ganglion cell complex thickness change (GCL+, GCL++)
Time frame: 1, 3, 6 month postoperatively
Mean retinal Sensitivity (MS)
Time frame: 1, 3, 6 month postoperatively
Central 2˚ and 4˚ fixation
Time frame: 1, 3, 6 month postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2023.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Face-down position time 1-day and Face-down position time 3-day in people with Idiopathic Macular Hole and Effective Prone Time, run by Tianjin Medical University Eye Hospital 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 4 inclusion and 5 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 7 Mar 2023. 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 Bojie Hu (13612130943, bhu07@tmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Macular hole closure rate (time frame: 6 month postoperatively). 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?
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 Mar 2023.