Cataract
Conditions
Keywords
cataract surgery, cornea protect, xerophthalmia, Corneal clarity
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.
Interventions
DEVICEHydroxypropyl ethylcellulose (HPMC) 2% gel
We use the hydroxypropyl ethylcellulose (HPMC) 2% gel instead of the traditional balanced salt solution during the cataract surgery.
DEVICEBSS
Balanced Salt Solution including normal saline and glucose
Sponsors
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
40 Years to 85 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change from baseline dry eye condition at 1 month | 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 | 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 | an expected average of a month after the surgery | Corneal damage evaluated by fluorescence staining of cornea |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Inflammation | an expected average of a month after the surgery | Inflammation evaluated by Anterior chamber scintillation |
| change from baseline dry eye condition at 1 week | an expected average of a week 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. |
Countries
China
Contacts
Primary ContactWangshu Yu, MD
Backup ContactXiuming Jin, PhD
Outcome results
None listed