Macular HolesNCT04957459
The Correlation of Preoperative Measurement Parameter on the Predicting of Visual Outcomes Among Patients With Idiopathic Macular Holes
An observational study of Macular Holes, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
This study retrospectively analyzed the relationship between the preoperative optical coherence tomography(OCT) and optical coherence tomography angiography(OCTA) software related parameters of patients with idiopathic macular hole, the patient's own clinical data and the best corrected visual acuity (BCVA) for at… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Macular Holes
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2020to 28 Feb 2022
- Phase
- Observational
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with idiopathic macular hole after vitrectomy combined with internal limiting membrane peeling and air-filling surgery and the MH is closed and the postoperative best corrected visual acuity is at least 1 month
Who may be able to join
- idiopathic MHs, the MH is closed ,and follow-up for at least 1 month after vitrectomy.
Who cannot join
- High myopia (≥6 diopters,AL≥26.5mm), increased intraocular pressure (IOP, >21 mm Hg) or glaucoma, severe cataract, severe corneal disease，severe systemic conditions that prevent surgery, and history of ocular trauma, intraocular inflammation, retinal vascular disease, or previous ocular surgery
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Ophthalmology, The Second Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang
Zhiyong Zhang, docter, 13968059392, zhangziyongnet@163.com
About this study
Official title: Prospective, Observational,Non-interventional Research of The Correlation of Preoperative Measurement Parameter on the Predicting of Visual Outcomes Among Patients With Idiopathic Macular Holes
This study retrospectively analyzed the relationship between the preoperative optical coherence tomography(OCT) and optical coherence tomography angiography(OCTA) software related parameters of patients with idiopathic macular hole, the patient's own clinical data and the best corrected visual acuity (BCVA) for at least one month after surgery.
Read the detailed description
After Pars plana vitrectomy combined with removal of the internal limiting membrane (ILM) and air filling, it can not only promote the closure of the macular hole in patients with idiopathic macular hole, but also improve the visual acuity of the affected eye. There are various studies to predict the visual acuity of patients after surgery recovery, but due to many factors that affect the effect of macular hole surgery, the improvement of visual acuity after retinal surgery varies greatly in different eyes. As a new type of ophthalmology device, OCTA plays an important role in measuring the size of the hole and the changes of retinal capillaries. Therefore, this study intends to calculate patient parameters based on OCT and OCTA equipment. Statistical software was used to analyze the relationship between each parameter and the best corrected visual acuity (BCVA) for at least one month after surgery.
- Conditions
- Macular Holes
- Being tested
- No intervention
- Keywords
- idiopathic full thickness macular hole, OCTA, postoperative best corrected visual acuity, vitrectomy
- Medical subject headings
- Retinal Perforations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
Macular hole status
macular hole status (open, flat open or closed)
Measured: at 1 month after surgery
MLD of macular hole
Calculation of minimum liner diameter of macular hole with optical coherence tomography angiography
Measured: Before surgery
BD of macular hole
Calculation of base diameter of macular hole with optical coherence tomography angiography
Measured: Before surgery
Choroidal hypertransmission width of macular hole
Calculation of Choroidal hypertransmission width of macular hole with optical coherence tomography angiography
Measured: Before surgery
Horizontal ellipsoid band missing diameter of macular hole
Calculation of Horizontal ellipsoid band missing diameter of macular hole with optical coherence tomography angiography
Measured: Before surgery
Baseline best-corrected visual acuity
best-corrected visual acuity were gauged with EDTRS charts,recorded in decimals and was converted to logarithm of the minimum angle of resolution units for statistical analysis
Measured: Before surgery
best-corrected visual acuity at 1 month
best-corrected visual acuity were gauged with EDTRS charts,recorded in decimals and was converted to logarithm of the minimum angle of resolution units for statistical analysis
Measured: at 1 month after surgery
best-corrected visual acuity at 2 months
best-corrected visual acuity were gauged with EDTRS charts,recorded in decimals and was converted to logarithm of the minimum angle of resolution units for statistical analysis
Measured: at 2 months after surgery
best-corrected visual acuity at 3 months
best-corrected visual acuity were gauged with EDTRS charts,recorded in decimals and was converted to logarithm of the minimum angle of resolution units for statistical analysis
Measured: at 3 months after surgery
best-corrected visual acuity at 4 months
best-corrected visual acuity were gauged with EDTRS charts,recorded in decimals and was converted to logarithm of the minimum angle of resolution units for statistical analysis
Measured: at 4 months after surgery
best-corrected visual acuity at 5 months
best-corrected visual acuity were gauged with EDTRS charts,recorded in decimals and was converted to logarithm of the minimum angle of resolution units for statistical analysis
Measured: at 5 months after surgery
best-corrected visual acuity at 6 months
best-corrected visual acuity were gauged with EDTRS charts,recorded in decimals and was converted to logarithm of the minimum angle of resolution units for statistical analysis
Measured: at 6 months after surgery
FAZ area of macular hole
Calculation of foveal avascular zone (FAZ) area of macular hole with optical coherence tomography angiography
Measured: Before surgery
FAZ area of macular hole at 1 month
Calculation of foveal avascular zone (FAZ) area of macular hole with optical coherence tomography angiography
Measured: at 1 month after surgery
FAZ area of macular hole at 2 months
Calculation of foveal avascular zone (FAZ) area of macular hole with optical coherence tomography angiography
Measured: at 2 months after surgery
FAZ area of macular hole at 3 months
Calculation of foveal avascular zone (FAZ) area of macular hole with optical coherence tomography angiography
Measured: at 3 months after surgery
FAZ area of macular hole at 4 months
Calculation of foveal avascular zone (FAZ) area of macular hole with optical coherence tomography angiography
Measured: at 4 months after surgery
FAZ area of macular hole at 5 months
Calculation of foveal avascular zone (FAZ) area of macular hole with optical coherence tomography angiography
Measured: at 5 months after surgery
FAZ area of macular hole at 6 months
Calculation of foveal avascular zone (FAZ) area of macular hole with optical coherence tomography angiography
Measured: at 6 months after surgery
CRT of macular hole
Calculation of central retinal thickness(CRT) of macular hole with optical coherence tomography angiography
Measured: Before surgery
CRT of macular hole at 1 month
Calculation of central retinal thickness(CRT) of macular hole with optical coherence tomography angiography
Measured: at 1 month after surgery
CRT of macular hole at 2 months
Calculation of central retinal thickness(CRT) of macular hole with optical coherence tomography angiography
Measured: at 2 months after surgery
CRT of macular hole at 3 months
Calculation of central retinal thickness(CRT) of macular hole with optical coherence tomography angiography
Measured: at 3 months after surgery
CRT of macular hole at 4 months
Calculation of central retinal thickness(CRT) of macular hole with optical coherence tomography angiography
Measured: at 4 months after surgery
CRT of macular hole at 5 months
Calculation of central retinal thickness(CRT) of macular hole with optical coherence tomography angiography
Measured: at 5 months after surgery
CRT of macular hole at 6 months
Calculation of central retinal thickness(CRT) of macular hole with optical coherence tomography angiography
Measured: at 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2021
- Study start1 Jan 2020
- Primary completion31 Dec 2021 (estimated)
- Study completion28 Feb 2022 (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.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Qi Wan, Principal investigator, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04957459
- Sponsor's protocol ID
- I2021001380
- Status last verified
- Jun 2021
- First submitted
- 8 Jun 2021
- Last updated
- 12 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- 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 12 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Observational,Non-interventional Research of The Correlation of Preoperative Measurement Parameter on the Predicting of Visual Outcomes Among Patients With Idiopathic Macular Holes
- ClinicalTrials.gov ID
- NCT04957459
- Acronym / sponsor ID
- I2021001380
- Conditions
- Macular Holes
- Keywords
- idiopathic full thickness macular hole, OCTA, postoperative best corrected visual acuity, vitrectomy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 28 Feb 2022 (estimated)
- First posted
- 12 Jul 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.
This study retrospectively analyzed the relationship between the preoperative optical coherence tomography(OCT) and optical coherence tomography angiography(OCTA) software related parameters of patients with idiopathic macular hole, the patient's own clinical data and the best corrected visual acuity (BCVA) for at least one month after surgery.
Detailed description
After Pars plana vitrectomy combined with removal of the internal limiting membrane (ILM) and air filling, it can not only promote the closure of the macular hole in patients with idiopathic macular hole, but also improve the visual acuity of the affected eye. There are various studies to predict the visual acuity of patients after surgery recovery, but due to many factors that affect the effect of macular hole surgery, the improvement of visual acuity after retinal surgery varies greatly in different eyes. As a new type of ophthalmology device, OCTA plays an important role in measuring the size of the hole and the changes of retinal capillaries. Therefore, this study intends to calculate patient parameters based on OCT and OCTA equipment. Statistical software was used to analyze the relationship between each parameter and the best corrected visual acuity (BCVA) for at least one month after surgery.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with idiopathic macular hole after vitrectomy combined with internal limiting membrane peeling and air-filling surgery and the MH is closed and the postoperative best corrected visual acuity is at least 1 month
Key inclusion criteria (1 listed)
- idiopathic MHs, the MH is closed ,and follow-up for at least 1 month after vitrectomy.
Key exclusion criteria (1 listed)
- High myopia (≥6 diopters,AL≥26.5mm), increased intraocular pressure (IOP, >21 mm Hg) or glaucoma, severe cataract, severe corneal disease，severe systemic conditions that prevent surgery, and history of ocular trauma, intraocular inflammation, retinal vascular disease, or previous 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 |
|---|---|---|
| No interventionNo intervention | Other | – |
Primary outcome
Macular hole status
Time frame: at 1 month after surgery
macular hole status (open, flat open or closed)
MLD of macular hole
Time frame: Before surgery
Calculation of minimum liner diameter of macular hole with optical coherence tomography angiography
BD of macular hole
Time frame: Before surgery
Calculation of base diameter of macular hole with optical coherence tomography angiography
Choroidal hypertransmission width of macular hole
Time frame: Before surgery
Calculation of Choroidal hypertransmission width of macular hole with optical coherence tomography angiography
Horizontal ellipsoid band missing diameter of macular hole
Time frame: Before surgery
Calculation of Horizontal ellipsoid band missing diameter of macular hole with optical coherence tomography angiography
Baseline best-corrected visual acuity
Time frame: Before surgery
best-corrected visual acuity were gauged with EDTRS charts,recorded in decimals and was converted to logarithm of the minimum angle of resolution units for statistical analysis
best-corrected visual acuity at 1 month
Time frame: at 1 month after surgery
best-corrected visual acuity were gauged with EDTRS charts,recorded in decimals and was converted to logarithm of the minimum angle of resolution units for statistical analysis
best-corrected visual acuity at 2 months
Time frame: at 2 months after surgery
best-corrected visual acuity were gauged with EDTRS charts,recorded in decimals and was converted to logarithm of the minimum angle of resolution units for statistical analysis
best-corrected visual acuity at 3 months
Time frame: at 3 months after surgery
best-corrected visual acuity were gauged with EDTRS charts,recorded in decimals and was converted to logarithm of the minimum angle of resolution units for statistical analysis
best-corrected visual acuity at 4 months
Time frame: at 4 months after surgery
best-corrected visual acuity were gauged with EDTRS charts,recorded in decimals and was converted to logarithm of the minimum angle of resolution units for statistical analysis
best-corrected visual acuity at 5 months
Time frame: at 5 months after surgery
best-corrected visual acuity were gauged with EDTRS charts,recorded in decimals and was converted to logarithm of the minimum angle of resolution units for statistical analysis
best-corrected visual acuity at 6 months
Time frame: at 6 months after surgery
best-corrected visual acuity were gauged with EDTRS charts,recorded in decimals and was converted to logarithm of the minimum angle of resolution units for statistical analysis
FAZ area of macular hole
Time frame: Before surgery
Calculation of foveal avascular zone (FAZ) area of macular hole with optical coherence tomography angiography
FAZ area of macular hole at 1 month
Time frame: at 1 month after surgery
Calculation of foveal avascular zone (FAZ) area of macular hole with optical coherence tomography angiography
FAZ area of macular hole at 2 months
Time frame: at 2 months after surgery
Calculation of foveal avascular zone (FAZ) area of macular hole with optical coherence tomography angiography
FAZ area of macular hole at 3 months
Time frame: at 3 months after surgery
Calculation of foveal avascular zone (FAZ) area of macular hole with optical coherence tomography angiography
FAZ area of macular hole at 4 months
Time frame: at 4 months after surgery
Calculation of foveal avascular zone (FAZ) area of macular hole with optical coherence tomography angiography
FAZ area of macular hole at 5 months
Time frame: at 5 months after surgery
Calculation of foveal avascular zone (FAZ) area of macular hole with optical coherence tomography angiography
FAZ area of macular hole at 6 months
Time frame: at 6 months after surgery
Calculation of foveal avascular zone (FAZ) area of macular hole with optical coherence tomography angiography
CRT of macular hole
Time frame: Before surgery
Calculation of central retinal thickness(CRT) of macular hole with optical coherence tomography angiography
CRT of macular hole at 1 month
Time frame: at 1 month after surgery
Calculation of central retinal thickness(CRT) of macular hole with optical coherence tomography angiography
CRT of macular hole at 2 months
Time frame: at 2 months after surgery
Calculation of central retinal thickness(CRT) of macular hole with optical coherence tomography angiography
CRT of macular hole at 3 months
Time frame: at 3 months after surgery
Calculation of central retinal thickness(CRT) of macular hole with optical coherence tomography angiography
CRT of macular hole at 4 months
Time frame: at 4 months after surgery
Calculation of central retinal thickness(CRT) of macular hole with optical coherence tomography angiography
CRT of macular hole at 5 months
Time frame: at 5 months after surgery
Calculation of central retinal thickness(CRT) of macular hole with optical coherence tomography angiography
CRT of macular hole at 6 months
Time frame: at 6 months after surgery
Calculation of central retinal thickness(CRT) of macular hole with optical coherence tomography angiography
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2021.
- 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.
Qi Wan principal investigator
Second Affiliated Hospital, Zhejiang University, School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Macular Holes, run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 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: status not confirmed, as of the sponsor's last update on 12 Jul 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 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 Zhiyong Zhang, docter (13968059392, zhangziyongnet@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Macular hole status (time frame: at 1 month after surgery). The study lists 26 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 12 Jul 2021.