Clinical trial NCT02363530: Corneal Protect Used During Cataract Surgery
Official title: Influence of 2% HPMC Used During Cataract Surgery for Intraoperative Corneal Optical Clarity and Post-operation Xerophthalmia.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cataract
Keywords: cataract surgery
cornea protect
xerophthalmia
Corneal clarity
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2015-02-16
Enrollment: 100
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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;
* 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.

Primary outcomes:
measure: change from baseline dry eye condition at 1 month
timeFrame: an expected average of a month after the surgery
measure: Intraoperative corneal clarity
timeFrame: during the surgery
measure: change from baseline corneal damage at 1 month
timeFrame: an expected average of a month after the surgery
Secondary outcomes:
measure: Inflammation
timeFrame: an expected average of a month after the surgery
measure: change from baseline dry eye condition at 1 week
timeFrame: an expected average of a week after the surgery
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Eye Center of the Second Affiliated Hospital of Zhejiang University
state: Zhejiang
Study officials:
affiliation: Eye Center of the Second Affiliated Hospital of Zhejiang University
name: Ke Yao, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.