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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
Zhongshan Ophthalmic Center, Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cataract

Eligibility Criteria

65 Years - 90 Years (Older Adult)All SexesAccepts Healthy Volunteers

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

First Posted
July 6, 2019
Last Updated
September 13, 2020
Sponsor
Zhongshan Ophthalmic Center, Sun Yat-sen University
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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

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Clinical Evaluation of Modified 2.2mm Microincision Phacoemulsification for Age-related Cataract

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