Corneal Protect Used During Cataract Surgery (CPUDCS)

Zhejiang University

Status: Unknown

Conditions: Cataract

Treatments: Device: BSS; Device: Hydroxypropyl ethylcellulose (HPMC) 2% gel

Study type: Interventional

Funder types: Other

Identifiers

NCT02363530

Corneal Protect

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 40 to 85 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups, including a placebo group

HPMC group

Experimental group

Description:

Patients use the intervention Hydroxypropyl ethylcellulose (HPMC) 2% gel during the cataract surgery.

Treatment:

Device: Hydroxypropyl ethylcellulose (HPMC) 2% gel

BSS group

Placebo Comparator group

Description:

Patients use balanced salt solution (BSS) during the cataract surgery.

Treatment:

Device: BSS