Macular HolesNCT06000111
Duration of Face Down Positioning for Full-Thickness Macular Hole Repair
A study testing 3 Days of face-down positioning and 7 Days of face-down positioning in people with Macular Holes, run by St. Joseph's Healthcare Hamilton at 1 site in Canada.
Trial summary
A full-thickness macular hole is when there is a small gap that opens in the center part of the retina (the light-sensitive layer of tissue in the back of the eye). Following surgical repair of these holes, patients have to lie face down for a number of days and nights. 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?
- 3 Days of face-down positioning and 7 Days of face-down positioning
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- 21 Nov 2023to 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
- Consecutive patients with an idiopathic full-thickness macular hole
- Symptom duration of less than 6 months
- Patient must agree to participate in this investigation
Who cannot join
- Macular hole minimum diameter >1000 μm
- A history of high myopia (> -6)
- Traumatic macular hole
- Amblyopia
- Retinal vein occlusion
- Inflammatory eye diseases
- Patients found to have a retinal tear during either the pre-operative assessment or intraoperatively
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
St. Joseph's Hospital King Campus
Stoney Creek, Ontario, L8G 5E4
Keean Nanji, MD, 6474575454, Keean.Nanji@medportal.ca
About this study
Official title: Duration of Face Down Positioning Following Full-Thickness Macular Hole Repair: a Randomized Feasibility Study
A full-thickness macular hole is when there is a small gap that opens in the center part of the retina (the light-sensitive layer of tissue in the back of the eye). Following surgical repair of these holes, patients have to lie face down for a number of days and nights. The exact amount of time necessary to position is however unknown. The goal of this randomized feasibility clinical trial is to compare 3 days and nights of face-down positioning to 7 days and nights of face-down positioning following pars plana vitrectomy surgery for full-thickness macular holes on key patient outcomes. This study will be a feasibility study to better inform a future larger clinical trial. Additionally, this investigation will be examining the rates of macular hole closure, patient visual acuity following surgery, patient quality of life, patient compliance, and complication rates.
- Conditions
- Macular Holes
- Being tested
- 3 Days of face-down positioning, 7 Days of face-down positioning
- Medical subject headings
- Retinal Perforations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3 Days of face-down positioningBehavioural
Following surgical repair, patients in the intervention group will maintain 3-days and nights of face-down positioning post-operatively.
7 Days of face-down positioningBehavioural
Following surgical repair, patients in the intervention group will maintain 7-days and nights of face-down positioning post-operatively.
| Study group | Role | What they receive |
|---|---|---|
| Face-Down Positioning for 3-Days and Nights | Experimental | Patients allocated to this study arm will maintain face-down positioning for 3-days and nights post-operatively. Patients will be advised to posture immediately following surgery and will be advised to posture for 50 minutes of each hour. Patients will be advised that during their 10-minute break each hour, they should avoid face-up positioning. FDP will be advised during both waking and sleeping hours. Receives: Behavioral: 3 Days of face-down positioning |
| Face-Down Positioning for 7-Days and Nights | Active comparator | Patients allocated to this study arm will maintain face-down positioning for 7-days and nights post-operatively. Patients will be advised to posture immediately following surgery and will be advised to posture for 50 minutes of each hour. Patients will be advised that during their 10-minute break each hour, they should avoid face-up positioning. FDP will be advised during both waking and sleeping hours. Receives: Behavioral: 7 Days of face-down positioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment Rate
This investigation's primary objective will be focused on assessing feasibility. One primary outcome will be to evaluate the recruitment rate of this study.
Measured: The recruitment rate will be calculated during the recruitment period.
Retention Rate
This investigation's primary objective will be focused on assessing feasibility. One primary outcome will be to evaluate the retention rate of this study.
Measured: The retention rate will be calculated at 3-months post-operatively.
Completion Rate
This investigation's primary objective will be focused on assessing feasibility. One primary outcome will be to evaluate the completion rate of this study.
Measured: The completion rate will be calculated at 3-months post-operatively.
Recruitment Time
This investigation's primary objective will be focused on assessing feasibility. One primary outcome will be to evaluate the recruitment time for this study.
Measured: The recruitment time will be calculated during the recruitment period.
Secondary outcomes (6)
Macular Hole Closure Rate
The rate of macular hole closure will be evaluated by 2-independent readers masked to treatment allocation. They will grade the outcome as open or closed. Outcomes classified as open will be further divided into open and flat (without a cuff of subretinal fluid) or open and elevated (with a cuff of subretinal fluid).
Measured: 3-months post-operatively
Best-Corrected Visual Acuity (BCVA)
Patient best-corrected visual acuity will be measured by Snellen visual acuity. With this measure of visual acuity, visual acuity can range from 20/10 (best) to 20/1000 (worst). If the patient is unable to read the chart at any distance, patients will next be assessed whether they can count figures at a given distance, if not, they will be tested to see whether they can perceive hand motion and if not, if they can perceive any light.
Measured: 3-months post-operatively
Vision specific quality of life measure
The National Eye Institute Visual Function Questionnaire (NEI VFQ-25) will be administered to patients. Possible patient scores range from 0 to 100 with a higher score representing higher vision-related quality of life.
Measured: 3-months post-operatively
Compliance with Face Down Positioning
Compliance will be assessed with self-administered questionnaires assessing the patients' compliance during the morning, midday, evening, and overnight. The possible range of scores is from 1 to 10 with higher scores indicating better compliance.
Measured: While the patient is positioning; this will either be for 3 days or 7 days depending on their treatment allocation.
Complication Rates
Specifically, the rates of endophthalmitis, retinal detachment, and vitreous hemorrhage
Measured: Rates will be determined for the entire follow-up period (3-months)
Health Related Quality of Life Measure
The Quality of Life Scale (QOLS) will be administered to patients. The range of possible patient scores is from 16 to 112. Higher scores indicate higher quality of life.
Measured: 3-months post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start21 Nov 2023
- Primary completion15 May 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- This study will be a single-centered, parallel group randomized controlled feasibility trial. Patients will be randomized 1:1 between groups.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Joseph's Healthcare Hamilton
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Varun Chaudhary, St. Joseph's Healthcare Hamilton
- Investigators
- Varun Chaudhary, MD, FRCSC, Principal investigator, McMaster University, St. Joseph's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06000111
- Sponsor's protocol ID
- 16100
- Status last verified
- Nov 2024
- First submitted
- 24 Jul 2023
- Last updated
- 29 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data may be shared with other researchers upon reasonable request.
Publications
Nanji K, Oquendo PL, Srinivasan S, Vyas C, Prasad F, Farrokhyar F, Chaudhary V. Duration of face down positioning following full-thickness macular hole repair: A protocol for a randomized pilot study. PLoS One. 2024 Aug 20;19(8):e0304566. doi: 10.1371/journal.pone.0304566. eCollection 2024.
PubMed 39163327
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Duration of Face Down Positioning Following Full-Thickness Macular Hole Repair: a Randomized Feasibility Study
- ClinicalTrials.gov ID
- NCT06000111
- Acronym / sponsor ID
- 16100
- Conditions
- Macular Holes
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- St. Joseph's Healthcare HamiltonUniversity, hospital or other
- Study start
- 21 Nov 2023 (actual)
- Primary completion
- 15 May 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 21 Aug 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.
A full-thickness macular hole is when there is a small gap that opens in the center part of the retina (the light-sensitive layer of tissue in the back of the eye). Following surgical repair of these holes, patients have to lie face down for a number of days and nights. The exact amount of time necessary to position is however unknown. The goal of this randomized feasibility clinical trial is to compare 3 days and nights of face-down positioning to 7 days and nights of face-down positioning following pars plana vitrectomy surgery for full-thickness macular holes on key patient outcomes. This study will be a feasibility study to better inform a future larger clinical trial. Additionally, this investigation will be examining the rates of macular hole closure, patient visual acuity following surgery, patient quality of life, patient compliance, and complication rates.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This study will be a single-centered, parallel group randomized controlled feasibility trial. Patients will be randomized 1:1 between groups.
| Arm | Type | Receives |
|---|---|---|
| Face-Down Positioning for 3-Days and Nights | Experimental | Behavioral: 3 Days of face-down positioningPatients allocated to this study arm will maintain face-down positioning for 3-days and nights post-operatively. Patients will be advised to posture immediately following surgery and will be advised to posture for 50 minutes of each hour. Patients will be advised that during their 10-minute break each hour, they should avoid face-up positioning. FDP will be advised during both waking and sleeping hours. |
| Face-Down Positioning for 7-Days and Nights | Active comparator | Behavioral: 7 Days of face-down positioningPatients allocated to this study arm will maintain face-down positioning for 7-days and nights post-operatively. Patients will be advised to posture immediately following surgery and will be advised to posture for 50 minutes of each hour. Patients will be advised that during their 10-minute break each hour, they should avoid face-up positioning. FDP will be advised during both waking and sleeping hours. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Consecutive patients with an idiopathic full-thickness macular hole
- Symptom duration of less than 6 months
- Patient must agree to participate in this investigation
Key exclusion criteria (7 listed)
- Macular hole minimum diameter >1000 μm
- A history of high myopia (> -6)
- Traumatic macular hole
- Amblyopia
- Retinal vein occlusion
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 |
|---|---|---|
| 3 Days of face-down positioningFollowing surgical repair, patients in the intervention group will maintain 3-days and nights of face-down positioning post-operatively. | Behavioural | Face-Down Positioning for 3-Days and Nights |
| 7 Days of face-down positioningFollowing surgical repair, patients in the intervention group will maintain 7-days and nights of face-down positioning post-operatively. | Behavioural | Face-Down Positioning for 7-Days and Nights |
Primary outcome
Recruitment Rate
Time frame: The recruitment rate will be calculated during the recruitment period.
This investigation's primary objective will be focused on assessing feasibility. One primary outcome will be to evaluate the recruitment rate of this study.
Retention Rate
Time frame: The retention rate will be calculated at 3-months post-operatively.
This investigation's primary objective will be focused on assessing feasibility. One primary outcome will be to evaluate the retention rate of this study.
Completion Rate
Time frame: The completion rate will be calculated at 3-months post-operatively.
This investigation's primary objective will be focused on assessing feasibility. One primary outcome will be to evaluate the completion rate of this study.
Recruitment Time
Time frame: The recruitment time will be calculated during the recruitment period.
This investigation's primary objective will be focused on assessing feasibility. One primary outcome will be to evaluate the recruitment time for this study.
6 secondary outcomes
Macular Hole Closure Rate
Time frame: 3-months post-operatively
Best-Corrected Visual Acuity (BCVA)
Time frame: 3-months post-operatively
Vision specific quality of life measure
Time frame: 3-months post-operatively
Compliance with Face Down Positioning
Time frame: While the patient is positioning; this will either be for 3 days or 7 days depending on their treatment allocation.
Complication Rates
Time frame: Rates will be determined for the entire follow-up period (3-months)
Health Related Quality of Life Measure
Time frame: 3-months post-operatively
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 29 Nov 2024.
- Derived from this study: PubMed 39163327Nanji K, Oquendo PL, Srinivasan S, Vyas C, Prasad F, Farrokhyar F, Chaudhary V. Duration of face down positioning following full-thickness macular hole repair: A protocol for a randomized pilot study. PLoS One. 2024 Aug 20;19(8):e0304566. doi: 10.1371/journal.pone.0304566. eCollection 2024.
- Individual participant dataSharing planned: No. Individual participant data may be shared with other researchers upon reasonable request.
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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.
Varun Chaudhary, MD, FRCSC principal investigator
McMaster University, St. Joseph's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3 Days of face-down positioning and 7 Days of face-down positioning in people with Macular Holes, run by St. Joseph's Healthcare Hamilton at 1 site in Canada.
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 3 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: looking for participants now, as of the sponsor's last update on 29 Nov 2024. 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 Canada. 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?
Contact Varun Chaudhary, MD, FRCSC (905-573-7777 ext. 38058, vchaudh@mcmaster.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment Rate (time frame: The recruitment rate will be calculated during the recruitment period.). The study lists 4 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 NCT06000111, which also lists 1 linked publication.
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 29 Nov 2024.