CataractNCT04100031
Efficacy of an Ocular Bandage Contact Lens for the Treatment of Dry Eye After Cataract Surgery
A study testing bandage contact lenses and phacoemulsification in people with Cataract and Dry Eye, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
To study the efficacy of an ocular bandage contact lens for the treatment of dry eye after cataract surgery Read more about this study
- Who is it for?
- Ages 60 years and older
- What is being tested?
- bandage contact lenses and phacoemulsification
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2018to 6 Dec 2020
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age-related cataract
- dry eye disease
Who cannot join
- a history of surgery and other ocular diseases
- contact lens use
- ocular therapies such as 0.05% cyclosporine A or steroids in the last 3 months. had 4.any systemic diseases such as heart diseases, diabetes and psychosis.
Trial locations and contacts
1 site in 1 country.
China1 site
Second Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009
About this study
To study the efficacy of an ocular bandage contact lens for the treatment of dry eye after cataract surgery
- Being tested
- bandage contact lenses, phacoemulsification
- Medical subject headings
- Cataract, Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bandage contact lensesDevice
wear bandage contact lensesfor a week after cataract surgery.
phacoemulsificationProcedure or surgery
underwent standard phacoemulsification through a 2.8-mm clear corneal temporal incision and intraocular lens
| Study group | Role | What they receive |
|---|---|---|
| BCL group | Experimental | Not described Receives: Device: bandage contact lenses; Procedure: phacoemulsification |
| control group | Active comparator | Not described Receives: Procedure: phacoemulsification |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Ocular Surface Disease Index at 1 week
Ocular Surface Disease Index
Measured: 0 day, 1 week postoperative
Change from Baseline Ocular Surface Disease Index at 1 month
Ocular Surface Disease Index
Measured: 0 day, 1 month postoperative
Change from Baseline meibography score at 1 week
meibography score
Measured: 0 day, 1 week postoperative
Change from Baseline meibography score at 1 month
meibography score
Measured: 0 day, 1 month postoperative
Change from Baseline of non-invasive keratograph tear meniscus height at 1 month
non-invasive keratograph tear meniscus height
Measured: 0 day, 1 month postoperative
Change from Baseline of non-invasive keratograph tear meniscus height at 1 week
non-invasive keratograph tear meniscus height
Measured: 0 day, 1 week postoperative
Change from Baseline noninvasive tear breakup time at 1 week
noninvasive tear breakup time
Measured: 0 day, 1 week postoperative
Change from Baseline noninvasive tear breakup time at 1 month
noninvasive tear breakup time
Measured: 0 day, 1 month postoperative
Change from Baseline Schirmer I test at 1 week
Schirmer I test
Measured: 0 day, 1 week postoperative
Change from Baseline Schirmer I test at 1 month
Schirmer I test
Measured: 0 day, 1 month postoperative
slit-lamp examination
slit-lamp examination
Measured: 0 day
Change from Baseline IL-1, IL-6, IL-12, IL-10, IL-8, TNF-α and ICAM-1 level at 1 month
cytokine levels
Measured: 0 day and 1 month postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2019
- Study start1 Sep 2018
- Primary completion6 Dec 2020
- Study completion6 Dec 2020
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 CataractStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04100031
- Sponsor's protocol ID
- xuwen2018-082
- Status last verified
- Jan 2021
- First submitted
- 18 Sep 2019
- Last updated
- 5 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wu X, Ma Y, Chen X, He S, Lin X, Yu X, Chen W, Luo C, Xu W. Efficacy of bandage contact lens for the management of dry eye disease after cataract surgery. Int Ophthalmol. 2021 Apr;41(4):1403-1413. doi: 10.1007/s10792-021-01692-6. Epub 2021 Jan 28.
PubMed 33507461
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of an Ocular Bandage Contact Lens for the Treatment of Dry Eye After Cataract Surgery
- ClinicalTrials.gov ID
- NCT04100031
- Acronym / sponsor ID
- xuwen2018-082
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 6 Dec 2020 (actual)
- Study completion
- 6 Dec 2020 (actual)
- First posted
- 23 Sep 2019 (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.
To study the efficacy of an ocular bandage contact lens for the treatment of dry eye after cataract surgery
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BCL group | Experimental | Device: bandage contact lenses, Procedure: phacoemulsification |
| control group | Active comparator | Procedure: phacoemulsification |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- age-related cataract
- dry eye disease
Key exclusion criteria (3 listed)
- a history of surgery and other ocular diseases
- contact lens use
- ocular therapies such as 0.05% cyclosporine A or steroids in the last 3 months. had 4.any systemic diseases such as heart diseases, diabetes and psychosis.
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 |
|---|---|---|
| bandage contact lenseswear bandage contact lensesfor a week after cataract surgery. | Device | BCL group |
| phacoemulsificationunderwent standard phacoemulsification through a 2.8-mm clear corneal temporal incision and intraocular lens | Procedure or surgery | BCL group, control group |
Primary outcome
Change from Baseline Ocular Surface Disease Index at 1 week
Time frame: 0 day, 1 week postoperative
Ocular Surface Disease Index
Change from Baseline Ocular Surface Disease Index at 1 month
Time frame: 0 day, 1 month postoperative
Ocular Surface Disease Index
Change from Baseline meibography score at 1 week
Time frame: 0 day, 1 week postoperative
meibography score
Change from Baseline meibography score at 1 month
Time frame: 0 day, 1 month postoperative
meibography score
Change from Baseline of non-invasive keratograph tear meniscus height at 1 month
Time frame: 0 day, 1 month postoperative
non-invasive keratograph tear meniscus height
Change from Baseline of non-invasive keratograph tear meniscus height at 1 week
Time frame: 0 day, 1 week postoperative
non-invasive keratograph tear meniscus height
Change from Baseline noninvasive tear breakup time at 1 week
Time frame: 0 day, 1 week postoperative
noninvasive tear breakup time
Change from Baseline noninvasive tear breakup time at 1 month
Time frame: 0 day, 1 month postoperative
noninvasive tear breakup time
Change from Baseline Schirmer I test at 1 week
Time frame: 0 day, 1 week postoperative
Schirmer I test
Change from Baseline Schirmer I test at 1 month
Time frame: 0 day, 1 month postoperative
Schirmer I test
slit-lamp examination
Time frame: 0 day
slit-lamp examination
Change from Baseline IL-1, IL-6, IL-12, IL-10, IL-8, TNF-α and ICAM-1 level at 1 month
Time frame: 0 day and 1 month postoperative
cytokine levels
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 5 Apr 2021.
- Derived from this study: PubMed 33507461Wu X, Ma Y, Chen X, He S, Lin X, Yu X, Chen W, Luo C, Xu W. Efficacy of bandage contact lens for the management of dry eye disease after cataract surgery. Int Ophthalmol. 2021 Apr;41(4):1403-1413. doi: 10.1007/s10792-021-01692-6. Epub 2021 Jan 28.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing bandage contact lenses and phacoemulsification in people with Cataract and Dry Eye, 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 2 inclusion and 3 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 5 Apr 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?
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?
Change from Baseline Ocular Surface Disease Index at 1 week (time frame: 0 day, 1 week postoperative). The study lists 12 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 NCT04100031, 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 5 Apr 2021.