Dysfunctional Lens Index Serves as a Novel Surgery Decision Maker for Age-related Cataracts
Primary Purpose
Age-related Cataract
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
a ray-tracing aberrometry
Sponsored by
About this trial
This is an interventional screening trial for Age-related Cataract
Eligibility Criteria
Inclusion Criteria:
- patients with age-related cataracts
Exclusion Criteria:
- any corneal opacity, corneal dystrophies, retinal anomalies, a history of ocular surgery or laser treatment, a LOCS III grade of cortical opacity ≥ 3.0 or posterior subcapsular cataract ≥ 2.0.
Sites / Locations
- Eye Hospital of Wenzhou Medical CollegeRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
cataract surgery
Arm Description
cataract extraction and intraocular implantation
Outcomes
Primary Outcome Measures
Dysfunctional lens index
The DLI is an objective lens performance metric derived from internal higher order aberrations (HOAs), pupil size, and contrast sensitivity data
Secondary Outcome Measures
Full Information
NCT ID
NCT03340389
First Posted
November 6, 2017
Last Updated
November 8, 2017
Sponsor
Wenzhou Medical University
1. Study Identification
Unique Protocol Identification Number
NCT03340389
Brief Title
Dysfunctional Lens Index Serves as a Novel Surgery Decision Maker for Age-related Cataracts
Official Title
Dysfunctional Lens Index Serves as a Novel Surgery Decision Maker for Age-related Cataracts
Study Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2017 (Actual)
Primary Completion Date
May 1, 2018 (Anticipated)
Study Completion Date
December 1, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wenzhou Medical 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
To study the correlations among the dysfunctional lens index (DLI), Lens Opacities Classification System III (LOCS III) nuclear opalescence grading score, preoperative corrected distance visual acuity (CDVA), the objective scatter index (OSI) and Scheimpflug based average lens density in age-related cataracts. To investigate the potential of the DLI as a novel surgery decision maker via the Operating Characteristic (ROC) curve analysis.
Detailed Description
Each patient received a comprehensive eye examination, including corrected distance visual acuity (CDVA) preoperatively and the day after surgery, subjective refraction, slit-lamp evaluation, noncontact tonometry (TX-F; Cannon, Tokyo, Japan), and dilated fundus examination. According to the surgery decision made by the three surgeons based on the slit lamp biomicroscopy and CDVA, patients were divided into two groups: Surgical and Non-Surgical. The results of the DLI, OSI and average lens density (ALD) were masked to the surgeons. The DLI, OSI, average lens density, LOCS III nuclear opalescence grading, and preoperative CDVA were obtained. Correlations among these parameters were analyzed. ROC curves were used to analyze DLI values to determine a value to separate between surgical and non-surgical cataracts.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Age-related Cataract
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
cataract surgery
Arm Type
Experimental
Arm Description
cataract extraction and intraocular implantation
Intervention Type
Procedure
Intervention Name(s)
a ray-tracing aberrometry
Intervention Description
The Dysfunctional Lens Index is obtained by a ray-tracing aberrometry
Primary Outcome Measure Information:
Title
Dysfunctional lens index
Description
The DLI is an objective lens performance metric derived from internal higher order aberrations (HOAs), pupil size, and contrast sensitivity data
Time Frame
6 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients with age-related cataracts
Exclusion Criteria:
any corneal opacity, corneal dystrophies, retinal anomalies, a history of ocular surgery or laser treatment, a LOCS III grade of cortical opacity ≥ 3.0 or posterior subcapsular cataract ≥ 2.0.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhangliang Li, MD
Phone
+86-571-88185666
Email
lizhangliang0328@126.com
Facility Information:
Facility Name
Eye Hospital of Wenzhou Medical College
City
Wenzhou
State/Province
Zhejiang
ZIP/Postal Code
325027
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
zhao Yinying, PhD
Phone
13957763247
Email
ginger146@126.com
12. IPD Sharing Statement
Plan to Share IPD
No
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Dysfunctional Lens Index Serves as a Novel Surgery Decision Maker for Age-related Cataracts
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