Back to resultsClinical Outcomes About Heparin Surface Modified Aspheric Lens
Primary Purpose
Inflammatory Reaction
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
traditional lens
heparin surface modified aspheric lens
Sponsored by
About this trial
This is an interventional treatment trial for Inflammatory Reaction
Eligibility Criteria
Inclusion Criteria:
- Cataract patients
Exclusion Criteria:
- Eyed patients
Sites / Locations
- The Affiliated Eye hospital of Wenzhou Medical University
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Heparin Surface Modified Aspheric Lens
traditional lens
Arm Description
Heparin Surface Modified Aspheric Lens
traditional Aspheric lens
Outcomes
Primary Outcome Measures
flare value in the anterior chamber after surgery
use Laser Flare Meter to measure the flare in the anterior chamber to evaluate postoperative ocular inflammatory reaction
Secondary Outcome Measures
the ocular and the anterior corneal aberration after surgery
use wavefront aberrometer to measure the ocular and the anterior corneal aberration to evaluate postoperative ocular optical quality
Full Information
NCT ID
NCT02026765
First Posted
December 17, 2013
Last Updated
December 8, 2015
Sponsor
Wenzhou Medical University
1. Study Identification
Unique Protocol Identification Number
NCT02026765
Brief Title
Clinical Outcomes About Heparin Surface Modified Aspheric Lens
Official Title
Clinical Outcomes About Heparin Surface Modified Aspheric Lens
Study Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wenzhou Medical University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to obverse the effect of this type lens in the same as traditional aspheric intraocular lens at the same time, whether can further improve the effects of operation.
Detailed Description
Heparin surface treatment lens can reduce inflammatory reaction.
Modified aspheric lens are more in line with human optical properties than the traditional aspheric lens.
To obverse the effect of this type lens in the same as traditional aspheric intraocular lens at the same time, whether can further improve the effects of operation.
After one day, one week, one month, three month follow-up，Key observation on the flare, the optical quality, contrast sensitivity and other parameters.Study the postoperative inflammatory reaction with test group lens，and the impact on the visual quality.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammatory Reaction
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Heparin Surface Modified Aspheric Lens
Arm Type
Other
Arm Description
Heparin Surface Modified Aspheric Lens
Arm Title
traditional lens
Arm Type
Other
Arm Description
traditional Aspheric lens
Intervention Type
Device
Intervention Name(s)
traditional lens
Intervention Description
A random eyes with traditional lens
Intervention Type
Device
Intervention Name(s)
heparin surface modified aspheric lens
Intervention Description
the other eye implant heparin surface modified aspheric lens
Primary Outcome Measure Information:
Title
flare value in the anterior chamber after surgery
Description
use Laser Flare Meter to measure the flare in the anterior chamber to evaluate postoperative ocular inflammatory reaction
Time Frame
six months
Secondary Outcome Measure Information:
Title
the ocular and the anterior corneal aberration after surgery
Description
use wavefront aberrometer to measure the ocular and the anterior corneal aberration to evaluate postoperative ocular optical quality
Time Frame
six months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Cataract patients
Exclusion Criteria:
Eyed patients
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AYong Yu, MD. PhD.
Organizational Affiliation
Wenzhou Medical University
Official's Role
Study Director
Facility Information:
Facility Name
The Affiliated Eye hospital of Wenzhou Medical University
City
Wenzhou
State/Province
Zhejiang
ZIP/Postal Code
325000
Country
China
12. IPD Sharing Statement
Learn more about this trial
Clinical Outcomes About Heparin Surface Modified Aspheric Lens
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