Back to resultsA Randomized Controlled Study of Phacoemulsification by the Enlarged Internal Incision and the Regular 2.2mm Incision
Primary Purpose
Cataract
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
enlarged internal incision
regular 2.2mm incision
Sponsored by
About this trial
This is an interventional prevention trial for Cataract
Eligibility Criteria
Inclusion Criteria:
- Age-related cataract patients
- Age from 65 to 90
- The diameter of pupil after mydriasis is more than 6 mm
- LOCS III nuclear grade ≥4
- Corneal endothelial cell count > 1500 cells/mm2
- Phacoemulsification and intraocular lens implantation are planned
- Agree to participate in this study and sign informed consent
Exclusion Criteria:
- History of ocular trauma
- Anterior segment lesions (exfoliation syndrome, suspension ligament injury or relaxation, corneal and iris lesions, glaucoma)
- Other ocular diseases that impair visual function, such as optic neuropathy, uveitis and ocular tumors
- History of Ophthalmic Surgery
- Intraoperative and Postoperative Complications
Sites / Locations
- Zhongshan Ophthalmic Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Enlarged internal incision
Regular 2.2mm incision
Arm Description
enlarged the internal incision about 0.4mm
regular 2.2mm corneal incision for microincision coaxial phacoemulsification
Outcomes
Primary Outcome Measures
descemet membrane detachment(DMD)
DMD at the incision observed by anterior segment optical coherence tomography
Secondary Outcome Measures
Full Information
NCT ID
NCT03976791
First Posted
June 4, 2019
Last Updated
June 11, 2019
Sponsor
Zhongshan Ophthalmic Center, Sun Yat-sen University
1. Study Identification
Unique Protocol Identification Number
NCT03976791
Brief Title
A Randomized Controlled Study of Phacoemulsification by the Enlarged Internal Incision and the Regular 2.2mm Incision
Official Title
A Randomized Controlled Study of Phacoemulsification by the Enlarged Internal Incision and the Regular 2.2mm Incision
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2019 (Anticipated)
Primary Completion Date
November 1, 2019 (Anticipated)
Study Completion Date
December 30, 2019 (Anticipated)
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
Objective and Principle: To evaluate whether enlarging the incision can reduce corneal complications associated with phacoemulsification with regular 2.2 mm incision.
The aim of this study: To evaluate whether the technique of enlarging internal incision could reduce the incidence of descemet membrane detachment after 2.2 mm incision phacoemulsification.
Secondary outcome: To evaluate whether the technique of enlarged internal incision can reduce other corneal complications such as corneal edema and astigmatism after 2.2 mm incision phacoemulsification.
Study Design: A prospective randomized controlled study
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
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
294 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Enlarged internal incision
Arm Type
Experimental
Arm Description
enlarged the internal incision about 0.4mm
Arm Title
Regular 2.2mm incision
Arm Type
Placebo Comparator
Arm Description
regular 2.2mm corneal incision for microincision coaxial phacoemulsification
Intervention Type
Procedure
Intervention Name(s)
enlarged internal incision
Intervention Description
enlarging the internal incision about 0.4mm
Intervention Type
Procedure
Intervention Name(s)
regular 2.2mm incision
Intervention Description
2.2mm microincision coaxial phacoemulsification
Primary Outcome Measure Information:
Title
descemet membrane detachment(DMD)
Description
DMD at the incision observed by anterior segment optical coherence tomography
Time Frame
postoperative 1 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age-related cataract patients
Age from 65 to 90
The diameter of pupil after mydriasis is more than 6 mm
LOCS III nuclear grade ≥4
Corneal endothelial cell count > 1500 cells/mm2
Phacoemulsification and intraocular lens implantation are planned
Agree to participate in this study and sign informed consent
Exclusion Criteria:
History of ocular trauma
Anterior segment lesions (exfoliation syndrome, suspension ligament injury or relaxation, corneal and iris lesions, glaucoma)
Other ocular diseases that impair visual function, such as optic neuropathy, uveitis and ocular tumors
History of Ophthalmic Surgery
Intraoperative and Postoperative Complications
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yizhi Liu, Doctor
Phone
87330475
Email
liuyizh@mail.sysu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yizhi Liu, Doctor
Organizational Affiliation
Zhongshan Ophthalmic Center, Sun Yat-sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zhongshan Ophthalmic Center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yizhi Liu, Doctor
12. IPD Sharing Statement
Learn more about this trial
A Randomized Controlled Study of Phacoemulsification by the Enlarged Internal Incision and the Regular 2.2mm Incision
We'll reach out to this number within 24 hrs