CataractCPUDCSNCT02363530
Corneal Protect Used During Cataract Surgery
A study testing Hydroxypropyl ethylcellulose (HPMC) 2% gel and BSS in people with Cataract, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
This randomized controlled subject- and examiner-masked study comprised patients scheduled for cataract surgery.The patients will be randomly assigned to receive either balanced salt solution（BSS）or hydroxypropyl methylcellulose（HPMC）2% gel （Cornea Protect）.Each subject should undertake examination including - rupture… Read more about this study
- Who is it for?
- Ages 40 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Cataract
- What is being tested?
- Hydroxypropyl ethylcellulose (HPMC) 2% gel and BSS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Nov 2014to Dec 2015
- 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 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- with cataracts;
- aged 40 to 85 years old, gender not limited;
- plans to accept PHACO and intraocular lens(IOL)implantation surgery
- the lens nucleus hardness level is less than 3 ;
- signed informed consent.
Who cannot join
- allergic to any of the drugs or device in this study ；
- existence of other infectious diseases or allergic conjunctivitis.
- the eye had been chemical burned or thermal burned
- diagnosed as Stevens Johnson syndrome or eye-pemphigoid.
- diagnosed with glaucoma or high intraocular pressure;
- existence of eyelid and lacrimal duct disease;
Show all 11Show fewer
- received any eye surgery in 3 months;
- wearing corneal contact lens;
- history suggests there are serious heart, lung, liver or renal function disorder;
- pregnancy or lactation women;
- Other conditions considered not appropriate by the investigators.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Eye Center of the Second Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang, 310003
Wangshu Yu, MD, 008615088733997, yuwangshu@zju.edu.cn
Xiuming Jin, PhD, 008613989455778, lzyjxm@zju.edu.cn
About this study
Official title: Influence of 2% HPMC Used During Cataract Surgery for Intraoperative Corneal Optical Clarity and Post-operation Xerophthalmia.
This randomized controlled subject- and examiner-masked study comprised patients scheduled for cataract surgery.The patients will be randomly assigned to receive either balanced salt solution（BSS）or hydroxypropyl methylcellulose（HPMC）2% gel （Cornea Protect）.Each subject should undertake examination including - rupture time (TBUT), height of the river of tears, fluorescence staining, Schirmer Ⅰ test, ocular surface disease index (OSDI) and self-conscious symptom assessment questionnaire for assessment.
Read the detailed description
This randomized controlled subject- and examiner-masked study comprised patients scheduled for cataract surgery.Over 100 patients will be randomly assigned to receive either balanced salt solution（BSS）or hydroxypropyl methylcellulose（HPMC）2% gel （Cornea Protect）.Each subject will accept 5 times assessments:the day before surgery, surgery day , the day after surgery,a week after surgery and a month after surgery.Each time a subject should undertake examination including - rupture time (TBUT), height of the river of tears, fluorescence staining, Schirmer Ⅰ test, ocular surface disease index (OSDI) and self-conscious symptom assessment questionnaire et.al.The purpose is to evaluate the effect of Cornea Protect to maintain intraoperative clarity and to prevent the postoperative xerophthalmia.
- Conditions
- Cataract
- Being tested
- Hydroxypropyl ethylcellulose (HPMC) 2% gel, BSS
- Keywords
- cataract surgery, cornea protect, xerophthalmia, Corneal clarity
- Medical subject headings
- Cataract, Xerophthalmia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydroxypropyl ethylcellulose (HPMC) 2% gelDevice
Also called Cornea Protect
We use the hydroxypropyl ethylcellulose (HPMC) 2% gel instead of the traditional balanced salt solution during the cataract surgery.
BSSDevice
Also called Balanced Salt Solution
Balanced Salt Solution including normal saline and glucose
| Study group | Role | What they receive |
|---|---|---|
| HPMC group | Experimental | Patients use the intervention Hydroxypropyl ethylcellulose (HPMC) 2% gel during the cataract surgery. Receives: Device: Hydroxypropyl ethylcellulose (HPMC) 2% gel |
| BSS group | Placebo comparator | Patients use balanced salt solution (BSS) during the cataract surgery. Receives: Device: BSS |
What is being measured
The primary outcome is the main question the study is designed to answer.
change from baseline dry eye condition at 1 month
Dry eye condition includes tear break up time (TBUT), height of the river of tears,Schirmer Ⅰ test,ocular surface disease index (OSDI) and self-conscious symptom assessment questionnaire.
Measured: an expected average of a month after the surgery
Intraoperative corneal clarity
record the times of using HPMC or BSS during the surgery to maintain the intraoperative corneal clarity and how long it lasts.
Measured: during the surgery
change from baseline corneal damage at 1 month
Corneal damage evaluated by fluorescence staining of cornea
Measured: an expected average of a month after the surgery
Secondary outcomes (2)
Inflammation
Inflammation evaluated by Anterior chamber scintillation
Measured: an expected average of a month after the surgery
change from baseline dry eye condition at 1 week
Dry eye condition includes tear break up time (TBUT), height of the river of tears,Schirmer Ⅰ test,ocular surface disease index (OSDI) and self-conscious symptom assessment questionnaire.
Measured: an expected average of a week after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2015 (estimated)
- Study startNov 2014
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (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.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wangshu Yu, Second Affiliated Hospital, Zhejiang University, School of Medicine
- Investigators
- Ke Yao, PhD, Principal investigator, Eye Center of the Second Affiliated Hospital of Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02363530
- Sponsor's protocol ID
- Corneal Protect
- Acronym
- CPUDCS
- Status last verified
- Nov 2015
- First submitted
- 5 Feb 2015
- Last updated
- 20 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Chen YA, Hirnschall N, Findl O. Comparison of corneal wetting properties of viscous eye lubricant and balanced salt solution to maintain optical clarity during cataract surgery. J Cataract Refract Surg. 2011 Oct;37(10):1806-8. doi: 10.1016/j.jcrs.2011.07.001. Epub 2011 Jul 22.
PubMed 21782381
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of 2% HPMC Used During Cataract Surgery for Intraoperative Corneal Optical Clarity and Post-operation Xerophthalmia.
- ClinicalTrials.gov ID
- NCT02363530
- Acronym / sponsor ID
- CPUDCS / Corneal Protect
- Conditions
- Cataract
- Keywords
- cataract surgery, cornea protect, xerophthalmia, Corneal clarity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 16 Feb 2015 (estimated)
- 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 randomized controlled subject- and examiner-masked study comprised patients scheduled for cataract surgery.The patients will be randomly assigned to receive either balanced salt solution（BSS）or hydroxypropyl methylcellulose（HPMC）2% gel （Cornea Protect）.Each subject should undertake examination including - rupture time (TBUT), height of the river of tears, fluorescence staining, Schirmer Ⅰ test, ocular surface disease index (OSDI) and self-conscious symptom assessment questionnaire for assessment.
Detailed description
This randomized controlled subject- and examiner-masked study comprised patients scheduled for cataract surgery.Over 100 patients will be randomly assigned to receive either balanced salt solution（BSS）or hydroxypropyl methylcellulose（HPMC）2% gel （Cornea Protect）.Each subject will accept 5 times assessments:the day before surgery, surgery day , the day after surgery,a week after surgery and a month after surgery.Each time a subject should undertake examination including - rupture time (TBUT), height of the river of tears, fluorescence staining, Schirmer Ⅰ test, ocular surface disease index (OSDI) and self-conscious symptom assessment questionnaire et.al.The purpose is to evaluate the effect of Cornea Protect to maintain intraoperative clarity and to prevent the postoperative xerophthalmia.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HPMC group | Experimental | Device: Hydroxypropyl ethylcellulose (HPMC) 2% gelPatients use the intervention Hydroxypropyl ethylcellulose (HPMC) 2% gel during the cataract surgery. |
| BSS group | Placebo comparator | Device: BSSPatients use balanced salt solution (BSS) during the cataract surgery. |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- with cataracts;
- aged 40 to 85 years old, gender not limited;
- plans to accept PHACO and intraocular lens(IOL)implantation surgery
- the lens nucleus hardness level is less than 3 ;
- signed informed consent.
Key exclusion criteria (11 listed)
- allergic to any of the drugs or device in this study ；
- existence of other infectious diseases or allergic conjunctivitis.
- the eye had been chemical burned or thermal burned
- diagnosed as Stevens Johnson syndrome or eye-pemphigoid.
- diagnosed with glaucoma or high intraocular pressure;
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 |
|---|---|---|
| Hydroxypropyl ethylcellulose (HPMC) 2% gelAlso: Cornea ProtectWe use the hydroxypropyl ethylcellulose (HPMC) 2% gel instead of the traditional balanced salt solution during the cataract surgery. | Device | HPMC group |
| BSSAlso: Balanced Salt SolutionBalanced Salt Solution including normal saline and glucose | Device | BSS group |
Primary outcome
change from baseline dry eye condition at 1 month
Time frame: an expected average of a month after the surgery
Dry eye condition includes tear break up time (TBUT), height of the river of tears,Schirmer Ⅰ test,ocular surface disease index (OSDI) and self-conscious symptom assessment questionnaire.
Intraoperative corneal clarity
Time frame: during the surgery
record the times of using HPMC or BSS during the surgery to maintain the intraoperative corneal clarity and how long it lasts.
change from baseline corneal damage at 1 month
Time frame: an expected average of a month after the surgery
Corneal damage evaluated by fluorescence staining of cornea
2 secondary outcomes
Inflammation
Time frame: an expected average of a month after the surgery
change from baseline dry eye condition at 1 week
Time frame: an expected average of a week after the surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2015.
- Results publication: PubMed 21782381Chen YA, Hirnschall N, Findl O. Comparison of corneal wetting properties of viscous eye lubricant and balanced salt solution to maintain optical clarity during cataract surgery. J Cataract Refract Surg. 2011 Oct;37(10):1806-8. doi: 10.1016/j.jcrs.2011.07.001. Epub 2011 Jul 22.
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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.
Ke Yao, PhD principal investigator
Eye Center of the Second Affiliated Hospital of Zhejiang University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hydroxypropyl ethylcellulose (HPMC) 2% gel and BSS in people with Cataract, 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 5 inclusion and 11 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 20 Nov 2015. 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. Some participants in this study may receive a placebo. 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 Wangshu Yu, MD (0086-15088733997, yuwangshu@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change from baseline dry eye condition at 1 month (time frame: an expected average of a month after the surgery). The study lists 3 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 NCT02363530, 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 20 Nov 2015.