Back to resultsThe Influences Of Anterior Capsule Polishing On Anterior Capsular Changes and Intraocular Lenses Stability of Super High Myopic Eyes
Primary Purpose
Myopia, High, With Cataract and Anterior Capsule Polished
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
360°anterior capsule polishing
Sponsored by
About this trial
This is an interventional other trial for Myopia, High, With Cataract and Anterior Capsule Polished
Eligibility Criteria
Inclusion Criteria:cataract patients with super high myopia (axial length >27mm) and difference of binocular was less than 1mm Exclusion Criteria:larger corneal astigmatism need toric intraocular lens; patients with any systemic or ocular diseases that may influence the anterior capsule opening morphologic, such as keratonosus, glaucoma, uveitis, Pseudoexfoliation syndrome, retinitis pigmentosa and diabetes and Myotonic Dystrophy, etc.; patients with ophthalmic surgery and trauma history.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
polished group
unpolished group
Arm Description
360°anterior capsule polishing was performed with double-ended capsule polisher randomly in one eye
the opposite unpolished was used as the control
Outcomes
Primary Outcome Measures
refraction
refractive state
anterior opening size
area,diameter
Stability of IOL
Tilt and Decentration
Secondary Outcome Measures
refraction
refractive state
refraction
refractive state
anterior opening size
area,diameter
anterior opening size
area,diameter
Stability of IOL
Tilt and Decentration
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03142269
Brief Title
The Influences Of Anterior Capsule Polishing On Anterior Capsular Changes and Intraocular Lenses Stability of Super High Myopic Eyes
Official Title
The Influences of 360° Anterior Capsule Polishing on Refraction, Anterior Capsular Opening Size and IOL Stability Among Super High Myopia Patients
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
January 1, 2015 (Actual)
Primary Completion Date
July 1, 2015 (Actual)
Study Completion Date
July 31, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
yin ying zhao
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
A prospective study included 20 patients with super high myopia who underwent bilateral uneventful cataract. 360°anterior capsule polishing was performed with double-ended capsule polisher randomly in one eye, and the opposite unpolished was used as the control. The refractive state and size of anterior opening were measured at postoperative 1 day as the baseline. Then they followed up at 1 month, 3 months and 6 months after surgery to record refractive state, higher-order aberrations, size of anterior opening, tilt and decentration of IOL (intraocular lenses)and PAD(postoperative aqueous depth). The paired t test was used to compare the differences between the two groups, and the same test the postoperative follow-up comparing with the baseline.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia, High, With Cataract and Anterior Capsule Polished
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
polished group
Arm Type
Active Comparator
Arm Description
360°anterior capsule polishing was performed with double-ended capsule polisher randomly in one eye
Arm Title
unpolished group
Arm Type
Placebo Comparator
Arm Description
the opposite unpolished was used as the control
Intervention Type
Procedure
Intervention Name(s)
360°anterior capsule polishing
Intervention Description
360°anterior capsule polishing was performed with double-ended capsule polisher
Primary Outcome Measure Information:
Title
refraction
Description
refractive state
Time Frame
Change from postoperative 1 day to 1 months
Title
anterior opening size
Description
area,diameter
Time Frame
Change from postoperative 1 day to 1 months
Title
Stability of IOL
Description
Tilt and Decentration
Time Frame
Change from postoperative 1 months to 3 months
Secondary Outcome Measure Information:
Title
refraction
Description
refractive state
Time Frame
Change from postoperative 1 month to 3 months
Title
refraction
Description
refractive state
Time Frame
Change from postoperative 3 month to 6 months
Title
anterior opening size
Description
area,diameter
Time Frame
Change from postoperative 1 month to 3 months
Title
anterior opening size
Description
area,diameter
Time Frame
Change from postoperative 3 month to 6 months
Title
Stability of IOL
Description
Tilt and Decentration
Time Frame
Change from postoperative 3 month to 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:cataract patients with super high myopia (axial length >27mm) and difference of binocular was less than 1mm Exclusion Criteria:larger corneal astigmatism need toric intraocular lens; patients with any systemic or ocular diseases that may influence the anterior capsule opening morphologic, such as keratonosus, glaucoma, uveitis, Pseudoexfoliation syndrome, retinitis pigmentosa and diabetes and Myotonic Dystrophy, etc.; patients with ophthalmic surgery and trauma history.
12. IPD Sharing Statement
Learn more about this trial
The Influences Of Anterior Capsule Polishing On Anterior Capsular Changes and Intraocular Lenses Stability of Super High Myopic Eyes
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