search
Back to results

Comparison of Wound Integrity for Clear Corneal Cataract Incisions

Primary Purpose

Cataract

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
pressure by a cotton swab
stromal hydration with the balanced salt solution(BSS)
Sponsored by
Zhongshan Ophthalmic Center, Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cataract

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Zhongshan Ophthalmic Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

cotton swab

balanced salt solution (BSS)

Arm Description

Outcomes

Primary Outcome Measures

Degree of incision closure
Degree of incision closure is evaluated by intraoperative optical coherence tomography.

Secondary Outcome Measures

Rate of wound leakage
Rate of wound leakage is evaluated by fluorescein sodium.
Corneal thickness
Corneal thickness is measured by Casia 2.
Corneal curvature
Corneal curvature is measured by Casia 2.
Anterior chamber depth
Anterior chamber depth is measured by Casia 2.
Rate of incision-related descemet membrane detachment during surgery
Rate of incision-related descemet membrane detachment is evaluated by intraoperative optical coherence tomography.
Rate of incision-related descemet membrane detachment after surgery
Rate of incision-related descemet membrane detachment after surgery is evaluated by Casia 2.

Full Information

First Posted
January 24, 2022
Last Updated
September 8, 2022
Sponsor
Zhongshan Ophthalmic Center, Sun Yat-sen University
search

1. Study Identification

Unique Protocol Identification Number
NCT05242653
Brief Title
Comparison of Wound Integrity for Clear Corneal Cataract Incisions
Official Title
Comparison of Wound Integrity for Clear Corneal Cataract Incisions: Pressure Versus Stromal Hydration
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
February 17, 2022 (Actual)
Primary Completion Date
June 30, 2022 (Actual)
Study Completion Date
September 8, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zhongshan Ophthalmic Center, Sun Yat-sen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
126 (Actual)

8. Arms, Groups, and Interventions

Arm Title
cotton swab
Arm Type
Experimental
Arm Title
balanced salt solution (BSS)
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
pressure by a cotton swab
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
stromal hydration with the balanced salt solution(BSS)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Degree of incision closure
Description
Degree of incision closure is evaluated by intraoperative optical coherence tomography.
Time Frame
During surgery
Secondary Outcome Measure Information:
Title
Rate of wound leakage
Description
Rate of wound leakage is evaluated by fluorescein sodium.
Time Frame
During surgery
Title
Corneal thickness
Description
Corneal thickness is measured by Casia 2.
Time Frame
1 hour after surgery and 1 day after surgery
Title
Corneal curvature
Description
Corneal curvature is measured by Casia 2.
Time Frame
1 hour after surgery and 1 day after surgery
Title
Anterior chamber depth
Description
Anterior chamber depth is measured by Casia 2.
Time Frame
1 hour after surgery and 1 day after surgery
Title
Rate of incision-related descemet membrane detachment during surgery
Description
Rate of incision-related descemet membrane detachment is evaluated by intraoperative optical coherence tomography.
Time Frame
During surgery
Title
Rate of incision-related descemet membrane detachment after surgery
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: > 18 years old; Nuclear grade is III or IV; Visually significant cataract; The patient is willing and able to complete all necessary follow-ups and examinations. Exclusion Criteria: Intraoperative or postoperative complications: such as intraoperative posterior capsule rupture, the rupture of zonule, secondary glaucoma, endophthalmitis, etc.; Combined with other eye diseases: such as keratopathy, glaucoma, uveitis, retinopathy, lens dislocation and ocular trauma, etc.; History of intraocular surgery; Severe systemic diseases: such as severe hypertension, diabetes, heart disease, Alzheimer's, Parkinson, etc.; Any condition that the study physician considers to be an impediment to the clinical trial.
Facility Information:
Facility Name
Zhongshan Ophthalmic Center
City
Guangzhou
State/Province
Guangdong
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Comparison of Wound Integrity for Clear Corneal Cataract Incisions

We'll reach out to this number within 24 hrs