Clinical Evaluation of Modified 2.2mm Microincision Phacoemulsification for Age-related Cataract
Primary Purpose
Cataract
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
modified 2.2mm microincision
conventional 2.2mm microincision
Sponsored by
About this trial
This is an interventional prevention trial for Cataract
Eligibility Criteria
Inclusion Criteria:
- Aged-related cataract patients between 65 and 90 years ;
- Lens nuclear opalescence grade ≥4.0 on the Lens Opacities Classification System III (LOCS III);
- Scheduled for phacoemulsification combined with intraocular lens implantation.
- The number of corneal endothelial cells > 1500cells/mm2.
- Dilated pupil diameter ≥6mm
Exclusion Criteria:
- A history of ophthalmic trauma or surgery;
- Other ophthalmic diseases such as glaucoma, uveitis, high myopia;
- Ocular factors that would make surgery challenging or dangerous, including but not limited to small pupil, shallow anterior chamber, etc.
Sites / Locations
- Zhongshan Ophthalmic Center, Sun Yat-sen University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
modified 2.2mm micoincision
conventional 2.2mm microincision
Arm Description
Outcomes
Primary Outcome Measures
Incidence of DMD at postoperative day 1
Incidence of incision-site descemet membrane detachment observed by anterior segment OCT at postoperative day 1
Secondary Outcome Measures
maximal incision thickness
maximal incision thickness measured by anterior segment OCT at postoperative day 1, day 7, month 1, month 3
surgical induced-astigmatism
surgical induced-astigmatism was calculated at each postoperative visit using the following equation: K2 = [K1 2 + K32 -2 K1 K3 cos (2θ3 -2θ1)]1/2
the length of DMD
the length of incision-site descemet membrane detachment measured by anterior segment OCT at postoperative day 1, day 7, month 1, month 3
Best corrected visual acuity (BCVA)
Best corrected visual acuity (BCVA) is evaluated with an ETDRS chart at each postoperative visit
modulation transfer function (MTF)-cut off
modulation transfer function (MTF)-cut off measured by itrace at each postoperative visit
central cornea endothelial cell loss
Central cornea endothelial cell loss was calculated on the basis of preoperative and postoperative endothelial cell density.
Full Information
NCT ID
NCT04014699
First Posted
July 6, 2019
Last Updated
September 13, 2020
Sponsor
Zhongshan Ophthalmic Center, Sun Yat-sen University
1. Study Identification
Unique Protocol Identification Number
NCT04014699
Brief Title
Clinical Evaluation of Modified 2.2mm Microincision Phacoemulsification for Age-related Cataract
Official Title
Clinical Evaluation of Modified 2.2mm Microincision Phacoemulsification for Age-related Cataract
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
July 22, 2019 (Actual)
Primary Completion Date
October 22, 2019 (Actual)
Study Completion Date
January 22, 2020 (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
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study is a single-center, parallel-group, randomized controlled trial with the following objectives: to compare the incidence of post-operative descemet membrane detachment (DMD) in phacoemulsification surgery between modified and conventional 2.2mm microincision.
Detailed Description
2.2mm incision is considered an ideal incision size in phacoemulsification. However, DMD is a common and serious complication in 2.2mm microincision phacoemulsification for hard nucleus age-related cataract. DMD is originated from the incision in the operation. How to construct the appropriate incision shape and size for reducing the occurrence of DMD is an important problem to be solved urgently in phacoemulsification surgery.
The investigators found that enlarging the internal incision could increase the range of motion of surgical instruments and reduce the friction of instruments to incision. Therefore,the incidence of DMD would be reduced. The investigators developed this technique, modified 2.2mm incision, to reduce the incidence of incision-site DMD and not to increase other incision related complications.
In this trial, the investigators aim to compare modified and conventional 2.2mm incision with regard to safety and efficacy in reducing the incidence of DMD.
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
130 (Actual)
8. Arms, Groups, and Interventions
Arm Title
modified 2.2mm micoincision
Arm Type
Experimental
Arm Title
conventional 2.2mm microincision
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
modified 2.2mm microincision
Intervention Description
enlarging the internal incision about 0.4mm for conventional 2.2mm coaxial microincision phacoemulsification
Intervention Type
Procedure
Intervention Name(s)
conventional 2.2mm microincision
Intervention Description
conventional 2.2mm coaxial microincision phacoemulsification
Primary Outcome Measure Information:
Title
Incidence of DMD at postoperative day 1
Description
Incidence of incision-site descemet membrane detachment observed by anterior segment OCT at postoperative day 1
Time Frame
postoperative day 1
Secondary Outcome Measure Information:
Title
maximal incision thickness
Description
maximal incision thickness measured by anterior segment OCT at postoperative day 1, day 7, month 1, month 3
Time Frame
postoperative day 1, day 7, month 1, month 3
Title
surgical induced-astigmatism
Description
surgical induced-astigmatism was calculated at each postoperative visit using the following equation: K2 = [K1 2 + K32 -2 K1 K3 cos (2θ3 -2θ1)]1/2
Time Frame
postoperative day 1, day 7, month 1, month 3
Title
the length of DMD
Description
the length of incision-site descemet membrane detachment measured by anterior segment OCT at postoperative day 1, day 7, month 1, month 3
Time Frame
postoperative day 1, day 7, month 1, month 3
Title
Best corrected visual acuity (BCVA)
Description
Best corrected visual acuity (BCVA) is evaluated with an ETDRS chart at each postoperative visit
Time Frame
postoperative day 1, day 7, month 1, month 3
Title
modulation transfer function (MTF)-cut off
Description
modulation transfer function (MTF)-cut off measured by itrace at each postoperative visit
Time Frame
postoperative day 1, day 7, month 1, month 3
Title
central cornea endothelial cell loss
Description
Central cornea endothelial cell loss was calculated on the basis of preoperative and postoperative endothelial cell density.
Time Frame
postoperative day 1, day 7, month 1, month 3
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:
Aged-related cataract patients between 65 and 90 years ;
Lens nuclear opalescence grade ≥4.0 on the Lens Opacities Classification System III (LOCS III);
Scheduled for phacoemulsification combined with intraocular lens implantation.
The number of corneal endothelial cells > 1500cells/mm2.
Dilated pupil diameter ≥6mm
Exclusion Criteria:
A history of ophthalmic trauma or surgery;
Other ophthalmic diseases such as glaucoma, uveitis, high myopia;
Ocular factors that would make surgery challenging or dangerous, including but not limited to small pupil, shallow anterior chamber, etc.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yizhi Liu, PhD
Organizational Affiliation
Zhongshan Ophthalmic Center, Sun Yat-sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zhongshan Ophthalmic Center, Sun Yat-sen University
City
Guangzhou
ZIP/Postal Code
510060
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
34647960
Citation
Dai Y, Liu Z, Wang W, Han X, Jin L, Chen X, Jin G, Wang L, Zhang E, Qu B, Liu J, Congdon N, He M, Luo L, Liu Y. Incidence of Incision-Related Descemet Membrane Detachment Using Phacoemulsification With Trapezoid vs Conventional 2.2-mm Clear Corneal Incision: A Randomized Clinical Trial. JAMA Ophthalmol. 2021 Nov 1;139(11):1228-1234. doi: 10.1001/jamaophthalmol.2021.4148.
Results Reference
derived
Learn more about this trial
Clinical Evaluation of Modified 2.2mm Microincision Phacoemulsification for Age-related Cataract
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