CataractNCT04120389
Efficacy of an Ocular Bandage Contact Lens for the Treatment of Dry Eye After Complicated and Combined Cataract Surgery
A study testing bandage contact lenses(PureVision; Bausch & Lomb Inc., Rochester, NY) and phacoemulsification in people with Cataract and Lens Subluxation, 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 complicated and combined cataract surgery Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Cataract, Lens Subluxation, Hypermature Cataract
- What is being tested?
- bandage contact lenses(PureVision; Bausch & Lomb Inc., Rochester, NY) and phacoemulsification
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 13 Mar 2020to 31 Dec 2021
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- cataract patients（age 40-80）
- complex symptom（such as:corneal opacity、small pupil、zonule relaxationlens subluxation、Shallow Anterior Chamber、hypermature cataract、hard nucleus,etc）
- dry eye disease
Who cannot join
- simplex age-related cataract
- contact lens use
- ocular therapies such as 0.05% cyclosporine A or steroids in the last 3 months
- any systemic diseases such as heart diseases, diabetes and psychosis
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Second Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009
wen xu, PHD, +86 571 87783897, xuwen2003@zju.edu.cn
About this study
To study the efficacy of an ocular bandage contact lens for the treatment of dry eye after complicated and combined cataract surgery
- Conditions
- Cataract, Lens Subluxation, Hypermature Cataract, Corneal Opacity, Small Pupil
- Being tested
- bandage contact lenses(PureVision; Bausch & Lomb Inc., Rochester, NY), phacoemulsification
- Keywords
- Bandage contact lens, cataract surgery, dry eye
- Medical subject headings
- Cataract, Lens Subluxation, Corneal Opacity, Miosis, Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bandage contact lenses(PureVision; Bausch & Lomb Inc., Rochester, NY)Device
wear an bandage contact lenses for a week after Complicated and Combined 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 | bandage contact lenses(PureVision; Bausch \& Lomb Inc., Rochester, NY) Receives: Device: bandage contact lenses(PureVision; Bausch & Lomb Inc., Rochester, NY); 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.
Ocular Surface Disease Index questionnaire
Ocular Surface Disease Index questionnaire were included 12 questions，and each was rated from 0-4
Measured: 0 day preoperatively
Ocular Surface Disease Index questionnaire
Ocular Surface Disease Index questionnaire were included 12 questions，and each was rated from 0-4
Measured: 1 day postoperatively
Ocular Surface Disease Index questionnaire
Ocular Surface Disease Index questionnaire were included 12 questions，and each was rated from 0-4
Measured: 1 week postoperatively
Ocular Surface Disease Index questionnaire
Ocular Surface Disease Index questionnaire were included 12 questions，and each was rated from 0-4
Measured: 1 month postoperatively
Ocular Surface Disease Index questionnaire
Ocular Surface Disease Index questionnaire were included 12 questions，and each was rated from 0-4
Measured: 3 months postoperatively
Tear Breakup Time
Tear Breakup Time was performed to assess tear film stability
Measured: 0 day preoperatively
Tear Breakup Time
Tear Breakup Time was performed to assess tear film stability
Measured: 1 week postoperatively
Tear Breakup Time
Tear Breakup Time was performed to assess tear film stability
Measured: 1 month postoperatively
Tear Breakup Time
Tear Breakup Time was performed to assess tear film stability
Measured: 3 months postoperatively
Schirmer test with anesthesia
The Schirmer test was performed by inserting a test strip
Measured: 0 day preoperatively
Schirmer test with anesthesia
The Schirmer test was performed by inserting a test strip
Measured: 1 week postoperatively
Schirmer test with anesthesia
The Schirmer test was performed by inserting a test strip
Measured: 1 month postoperatively
Schirmer test with anesthesia
The Schirmer test was performed by inserting a test strip
Measured: 3 months postoperatively
Secondary outcomes (9)
Subjective symptoms
Subjective symptoms evaluation related to 11 ocular symptoms ，and each was graded as follows：0 never、1 occasional、2 often、3 always
Measured: 0 day preoperatively
Subjective symptoms
Subjective symptoms evaluation related to 11 ocular symptoms ，and each was graded as follows：0 never、1 occasional、2 often、3 always
Measured: 1 day postoperatively
Subjective symptoms
Subjective symptoms evaluation related to 11 ocular symptoms ，and each was graded as follows：0 never、1 occasional、2 often、3 always
Measured: 1 week postoperatively
Subjective symptoms
Subjective symptoms evaluation related to 11 ocular symptoms ，and each was graded as follows：0 never、1 occasional、2 often、3 always
Measured: 1 month postoperatively
Subjective symptoms
Subjective symptoms evaluation related to 11 ocular symptoms ，and each was graded as follows：0 never、1 occasional、2 often、3 always
Measured: 3 months postoperatively
Fluorescein Staining
The corneal surface was divided into four regions, and each region was scored as follows: 0, no staining; 1, between one and three dots; 2, less than five dots; and 3, bulk or strip staining. The four regions scores were then added to obtain a final score for the eye
Measured: 0 day preoperatively
Fluorescein Staining
The corneal surface was divided into four regions, and each region was scored as follows: 0, no staining; 1, between one and three dots; 2, less than five dots; and 3, bulk or strip staining. The four regions scores were then added to obtain a final score for the eye
Measured: 1 week postoperatively
Fluorescein Staining
The corneal surface was divided into four regions, and each region was scored as follows: 0, no staining; 1, between one and three dots; 2, less than five dots; and 3, bulk or strip staining. The four regions scores were then added to obtain a final score for the eye
Measured: 1 month postoperatively
Fluorescein Staining
The corneal surface was divided into four regions, and each region was scored as follows: 0, no staining; 1, between one and three dots; 2, less than five dots; and 3, bulk or strip staining. The four regions scores were then added to obtain a final score for the eye
Measured: 3 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2019
- Study start13 Mar 2020
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (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 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04120389
- Sponsor's protocol ID
- xuwen2019-929
- Status last verified
- Jan 2021
- First submitted
- 29 Sep 2019
- Last updated
- 5 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Chen D, Xu D, Wu X, Wang J, Sheng S, Yu X, Lin X, Liu L, Ge X, Zhao H, Xu W. The efficacy of bandage contact lens in relieving the aggravation of dry eye disease after complicated cataract or/and IOL surgery. BMC Ophthalmol. 2024 Mar 28;24(1):141. doi: 10.1186/s12886-024-03385-x.
PubMed 38549070
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 Complicated and Combined Cataract Surgery
- ClinicalTrials.gov ID
- NCT04120389
- Acronym / sponsor ID
- xuwen2019-929
- Conditions
- Cataract, Lens Subluxation, Hypermature Cataract, Corneal Opacity, Small Pupil
- Keywords
- Bandage contact lens, cataract surgery, dry eye
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 13 Mar 2020 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 9 Oct 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 complicated and combined cataract surgery
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BCL group | Experimental | Device: bandage contact lenses(PureVision; Bausch & Lomb Inc., Rochester, NY), Procedure: phacoemulsificationbandage contact lenses(PureVision; Bausch \& Lomb Inc., Rochester, NY) |
| control group | Active comparator | Procedure: phacoemulsification |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- cataract patients（age 40-80）
- complex symptom（such as:corneal opacity、small pupil、zonule relaxationlens subluxation、Shallow Anterior Chamber、hypermature cataract、hard nucleus,etc）
- dry eye disease
Key exclusion criteria (4 listed)
- simplex age-related cataract
- contact lens use
- ocular therapies such as 0.05% cyclosporine A or steroids in the last 3 months
- 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 lenses(PureVision; Bausch & Lomb Inc., Rochester, NY)wear an bandage contact lenses for a week after Complicated and Combined 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
Ocular Surface Disease Index questionnaire
Time frame: 0 day preoperatively
Ocular Surface Disease Index questionnaire were included 12 questions，and each was rated from 0-4
Ocular Surface Disease Index questionnaire
Time frame: 1 day postoperatively
Ocular Surface Disease Index questionnaire were included 12 questions，and each was rated from 0-4
Ocular Surface Disease Index questionnaire
Time frame: 1 week postoperatively
Ocular Surface Disease Index questionnaire were included 12 questions，and each was rated from 0-4
Ocular Surface Disease Index questionnaire
Time frame: 1 month postoperatively
Ocular Surface Disease Index questionnaire were included 12 questions，and each was rated from 0-4
Ocular Surface Disease Index questionnaire
Time frame: 3 months postoperatively
Ocular Surface Disease Index questionnaire were included 12 questions，and each was rated from 0-4
Tear Breakup Time
Time frame: 0 day preoperatively
Tear Breakup Time was performed to assess tear film stability
Tear Breakup Time
Time frame: 1 week postoperatively
Tear Breakup Time was performed to assess tear film stability
Tear Breakup Time
Time frame: 1 month postoperatively
Tear Breakup Time was performed to assess tear film stability
Tear Breakup Time
Time frame: 3 months postoperatively
Tear Breakup Time was performed to assess tear film stability
Schirmer test with anesthesia
Time frame: 0 day preoperatively
The Schirmer test was performed by inserting a test strip
Schirmer test with anesthesia
Time frame: 1 week postoperatively
The Schirmer test was performed by inserting a test strip
Schirmer test with anesthesia
Time frame: 1 month postoperatively
The Schirmer test was performed by inserting a test strip
Schirmer test with anesthesia
Time frame: 3 months postoperatively
The Schirmer test was performed by inserting a test strip
9 secondary outcomes
Subjective symptoms
Time frame: 0 day preoperatively
Subjective symptoms
Time frame: 1 day postoperatively
Subjective symptoms
Time frame: 1 week postoperatively
Subjective symptoms
Time frame: 1 month postoperatively
Subjective symptoms
Time frame: 3 months postoperatively
Fluorescein Staining
Time frame: 0 day preoperatively
Fluorescein Staining
Time frame: 1 week postoperatively
Fluorescein Staining
Time frame: 1 month postoperatively
Fluorescein Staining
Time frame: 3 months postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2021.
- Derived from this study: PubMed 38549070Chen D, Xu D, Wu X, Wang J, Sheng S, Yu X, Lin X, Liu L, Ge X, Zhao H, Xu W. The efficacy of bandage contact lens in relieving the aggravation of dry eye disease after complicated cataract or/and IOL surgery. BMC Ophthalmol. 2024 Mar 28;24(1):141. doi: 10.1186/s12886-024-03385-x.
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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 bandage contact lenses(PureVision; Bausch & Lomb Inc., Rochester, NY) and phacoemulsification in people with Cataract and Lens Subluxation, 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 3 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: status not confirmed, 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact wen xu, PHD (+86 571 87783897, xuwen2003@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ocular Surface Disease Index questionnaire (time frame: 0 day preoperatively). The study lists 13 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 NCT04120389, 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.