Comparison of Wound Integrity for Clear Corneal Cataract Incisions

Cataract Clinical Trial

Official title:

Comparison of Wound Integrity for Clear Corneal Cataract Incisions: Pressure Versus Stromal Hydration

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05242653
• Other study ID #: 2021KYPJ208
• Status: Completed
• Phase: N/A
• Start date: February 17, 2022
• Est. completion date: September 8, 2022

Study information

• Verified date: September 2022
• Source: Zhongshan Ophthalmic Center, Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a randomized controlled trial to evaluate the safety and efficacy of two different closing methods for clear corneal cataract incisions

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: September 8, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

1. > 18 years old;

2. Nuclear grade is III or IV;

3. Visually significant cataract;

4. The patient is willing and able to complete all necessary follow-ups and examinations.

Exclusion Criteria:

1. Intraoperative or postoperative complications: such as intraoperative posterior capsule rupture, the rupture of zonule, secondary glaucoma, endophthalmitis, etc.;

2. Combined with other eye diseases: such as keratopathy, glaucoma, uveitis, retinopathy, lens dislocation and ocular trauma, etc.;

3. History of intraocular surgery;

4. Severe systemic diseases: such as severe hypertension, diabetes, heart disease, Alzheimer's, Parkinson, etc.;

5. Any condition that the study physician considers to be an impediment to the clinical trial.

Related Conditions & MeSH terms

• Cataract

Intervention

Procedure:
• 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 pressure by a cotton swab.
• stromal hydration with the balanced salt solution(BSS)
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.

Locations

Country	Name	City	State
China	Zhongshan Ophthalmic Center	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Zhongshan Ophthalmic Center, Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Degree of incision closure	Degree of incision closure is evaluated by intraoperative optical coherence tomography.	During surgery
Secondary	Rate of wound leakage	Rate of wound leakage is evaluated by fluorescein sodium.	During surgery
Secondary	Corneal thickness	Corneal thickness is measured by Casia 2.	1 hour after surgery and 1 day after surgery
Secondary	Corneal curvature	Corneal curvature is measured by Casia 2.	1 hour after surgery and 1 day after surgery
Secondary	Anterior chamber depth	Anterior chamber depth is measured by Casia 2.	1 hour after surgery and 1 day after surgery
Secondary	Rate of incision-related descemet membrane detachment during surgery	Rate of incision-related descemet membrane detachment is evaluated by intraoperative optical coherence tomography.	During surgery
Secondary	Rate of incision-related descemet membrane detachment after surgery	Rate of incision-related descemet membrane detachment after surgery is evaluated by Casia 2.	1 hour after surgery and 1 day after surgery