Meibomian Gland DysfunctionNCT04667871
Effect of Cataract Hyperemulsification Surgery on Meibomian Gland Morphology and Function
An observational study of Meibomian Gland Dysfunction, run by Yune Zhao.
Trial summary
50 participants at Eye Hospital of Wenzhou Medical University during August, 2017 to July, 2020 will be enrolled in this study. To study the effect of cataract supermammary surgery on the morphology and function of meibomian glands Read more about this study
- Who is it for?
- Ages 38 to 87 years
- Conditions the study is for
- Meibomian Gland Dysfunction
- What is being tested?
- cataract surgery
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2017to 1 Sep 2020
- 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 38 to 87 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Those patients who undergoing cataract hyperemulsification surgery and previously untreated with xerophthalmia.
Who may be able to join
- Previously untreated patients with xerophthalmia
- Undergoing cataract hyperemulsification surgery
Who cannot join
- No history of ocular surgery and trauma
- Any eye diseases except xerophthalmia
- No treated for xerophthalmia before
- Successful completion of follow-ups
About this study
50 participants at Eye Hospital of Wenzhou Medical University during August, 2017 to July, 2020 will be enrolled in this study. To study the effect of cataract supermammary surgery on the morphology and function of meibomian glands
- Conditions
- Meibomian Gland Dysfunction
- Being tested
- cataract surgery
- Keywords
- meibomian gland, cataract surgery
- Medical subject headings
- Meibomian Gland Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cataract surgeryProcedure or surgery
Eyes for cataract surgery
| Study group | Role | What they receive |
|---|---|---|
| Eyes for cataract surgery | Eyes for cataract surgery Receives: Procedure: cataract surgery | |
| Eyes without cataract surgery | Eyes without cataract surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
OSDI scale survey
OSDI scale survey
Measured: 08/2017 to 07/2020
tear meniscus height（mm）
tear meniscus height（mm）
Measured: 08/2017 to 07/2020
first tear film rupture time（s）
first tear film rupture time（s）
Measured: 08/2017 to 07/2020
average tear film rupture time（s）
average tear film rupture time（s）
Measured: 08/2017 to 07/2020
the range of meibomian gland missing（%）
the range of meibomian gland missing（%）
Measured: 08/2017 to 07/2020
meibomian gland average diameter (mm)
meibomian gland average diameter (mm)
Measured: 08/2017 to 07/2020
meibomian gland length (mm)
meibomian gland length (mm)
Measured: 08/2017 to 07/2020
meibomian gland area (mm^2)
meibomian gland area (mm^2)
Measured: 08/2017 to 07/2020
meibomian gland deformation coefficient
meibomian gland deformation coefficient
Measured: 08/2017 to 07/2020
meibomian gland total proportion of glands (%)
meibomian gland total proportion of glands (%)
Measured: 08/2017 to 07/2020
meibomian gland imaging value
meibomian gland imaging value
Measured: 08/2017 to 07/2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2020
- Study start1 Aug 2017
- Primary completion1 Jul 2020
- Study completion1 Sep 2020
Why it stopped: An six-month follow-up was completed after the treatment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Meibomian Gland DysfunctionStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yune Zhao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yune Zhao, Wenzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04667871
- Sponsor's protocol ID
- XZZ-meibomian gland
- Status last verified
- Nov 2020
- First submitted
- 4 Oct 2020
- Last updated
- 16 Dec 2020
- 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 16 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Cataract Hyperemulsification Surgery on Meibomian Gland Morphology and Function
- ClinicalTrials.gov ID
- NCT04667871
- Acronym / sponsor ID
- XZZ-meibomian gland
- Conditions
- Meibomian Gland Dysfunction
- Keywords
- meibomian gland, cataract surgery
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: An six-month follow-up was completed after the treatment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Yune ZhaoUniversity, hospital or other
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 1 Jul 2020 (actual)
- Study completion
- 1 Sep 2020 (actual)
- First posted
- 16 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.
50 participants at Eye Hospital of Wenzhou Medical University during August, 2017 to July, 2020 will be enrolled in this study. To study the effect of cataract supermammary surgery on the morphology and function of meibomian glands
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Eyes for cataract surgery | – | Procedure: cataract surgeryEyes for cataract surgery |
| Eyes without cataract surgery | – | –Eyes without cataract surgery |
Who may qualify
- Ages
- 38 to 87 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Those patients who undergoing cataract hyperemulsification surgery and previously untreated with xerophthalmia.
Key inclusion criteria (2 listed)
- Previously untreated patients with xerophthalmia
- Undergoing cataract hyperemulsification surgery
Key exclusion criteria (4 listed)
- No history of ocular surgery and trauma
- Any eye diseases except xerophthalmia
- No treated for xerophthalmia before
- Successful completion of follow-ups
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 |
|---|---|---|
| cataract surgeryEyes for cataract surgery | Procedure or surgery | Eyes for cataract surgery |
Primary outcome
OSDI scale survey
Time frame: 08/2017 to 07/2020
OSDI scale survey
tear meniscus height（mm）
Time frame: 08/2017 to 07/2020
tear meniscus height（mm）
first tear film rupture time（s）
Time frame: 08/2017 to 07/2020
first tear film rupture time（s）
average tear film rupture time（s）
Time frame: 08/2017 to 07/2020
average tear film rupture time（s）
the range of meibomian gland missing（%）
Time frame: 08/2017 to 07/2020
the range of meibomian gland missing（%）
meibomian gland average diameter (mm)
Time frame: 08/2017 to 07/2020
meibomian gland average diameter (mm)
meibomian gland length (mm)
Time frame: 08/2017 to 07/2020
meibomian gland length (mm)
meibomian gland area (mm^2)
Time frame: 08/2017 to 07/2020
meibomian gland area (mm^2)
meibomian gland deformation coefficient
Time frame: 08/2017 to 07/2020
meibomian gland deformation coefficient
meibomian gland total proportion of glands (%)
Time frame: 08/2017 to 07/2020
meibomian gland total proportion of glands (%)
meibomian gland imaging value
Time frame: 08/2017 to 07/2020
meibomian gland imaging value
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2020.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Meibomian Gland Dysfunction, run by Yune Zhao.
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 2 inclusion and 4 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: withdrawn, as of the sponsor's last update on 16 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 was withdrawn before enrolling participants, so there are no results.
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?
OSDI scale survey (time frame: 08/2017 to 07/2020). The study lists 11 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 16 Dec 2020.