This is a randomized controlled trial to evaluate the safety and efficacy of two different closing methods for clear corneal cataract incisions
Compared with other incision types , clear corneal incision has the advantages of simple operation, small incision and good healing. It has been widely used in recent decades and has become the most commonly used incision type in phacoemulsification cataract surgery.However, there is no unified standard for the closed method of the clear corneal incision, and some studies have shown that the wound Integrity of clear corneal incision is not well.In the poorly closed incision, the risk of infection increased due to the leakage .Especially in 2.2mm incision, the frequent entry and exit of the instrument reduces the corneal rebound ability at the incision so that the incision is hard to closed. Ensuring wound Integrity for clear corneal cataract incision is the key to the success of cataract surgery. Clinically closed methods include stromal hydration and suture.The effectiveness of stromal hydration as one of the most commonly used methods has been validated, but also adds additional negative effects. Additionally, the suture extends the operation time and improves the operation cost, and is also accompanied by some complications, which has been less used. Exploring a safe and effective closed method will benefit for most cataract patients. This study intends to evaluate the safety and efficacy of a closed method that incision is pressed by a cotton swab.The investigators planned to select 130 cataract patients who met the inclusion criteria. The investigators will press the clear corneal incision with a cotton swab in experimental group, while the control group used stromal hydration to close the corneal incision. Wound Integrity, wound leakage, corneal thickness at the incision, keratometric value at the incision, anterior chamber depth and incidence of incision-related descemet membrane detachment were compared between the two groups.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
126
All patients undergo uneventful phacoemulsification by a 2.2 mm temporal transparent corneal incision using Centurion Vision System (Alcon Laboratories, Fort Worth, TX, USA). After the nucleus and cortex are removed, IOL is implanted in the capsular bag. Finally, the clear corneal incision is closed with pressure by a cotton swab.
All patients undergo uneventful phacoemulsification by a 2.2 mm temporal transparent corneal incision using Centurion Vision System (Alcon Laboratories, Fort Worth, TX, USA). After the nucleus and cortex are removed, IOL is implanted in the capsular bag. Finally, the clear corneal incision is closed with stromal hydration.
Zhongshan Ophthalmic Center
Guangzhou, Guangdong, China
Degree of incision closure
Degree of incision closure is evaluated by intraoperative optical coherence tomography.
Time frame: During surgery
Rate of wound leakage
Rate of wound leakage is evaluated by fluorescein sodium.
Time frame: During surgery
Corneal thickness
Corneal thickness is measured by Casia 2.
Time frame: 1 hour after surgery and 1 day after surgery
Corneal curvature
Corneal curvature is measured by Casia 2.
Time frame: 1 hour after surgery and 1 day after surgery
Anterior chamber depth
Anterior chamber depth is measured by Casia 2.
Time frame: 1 hour after surgery and 1 day after surgery
Rate of incision-related descemet membrane detachment during surgery
Rate of incision-related descemet membrane detachment is evaluated by intraoperative optical coherence tomography.
Time frame: During surgery
Rate of incision-related descemet membrane detachment after surgery
Rate of incision-related descemet membrane detachment after surgery is evaluated by Casia 2.
Time frame: 1 hour after surgery and 1 day after surgery
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