The Influences Of Anterior Capsule Polishing On Anterior Capsular Changes and Intraocular Lenses Stability of Super High Myopic Eyes

May 2, 2017 updated by: yin ying zhao

The Influences of 360° Anterior Capsule Polishing on Refraction, Anterior Capsular Opening Size and IOL Stability Among Super High Myopia Patients

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: polished group
360°anterior capsule polishing was performed with double-ended capsule polisher randomly in one eye
Procedure: 360°anterior capsule polishing
360°anterior capsule polishing was performed with double-ended capsule polisher
Placebo Comparator: unpolished group
the opposite unpolished was used as the control
Procedure: 360°anterior capsule polishing
360°anterior capsule polishing was performed with double-ended capsule polisher

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
refraction
Time Frame: Change from postoperative 1 day to 1 months
refractive state
Change from postoperative 1 day to 1 months
anterior opening size
Time Frame: Change from postoperative 1 day to 1 months
area,diameter
Change from postoperative 1 day to 1 months
Stability of IOL
Time Frame: Change from postoperative 1 months to 3 months
Tilt and Decentration
Change from postoperative 1 months to 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
refraction
Time Frame: Change from postoperative 1 month to 3 months
refractive state
Change from postoperative 1 month to 3 months
refraction
Time Frame: Change from postoperative 3 month to 6 months
refractive state
Change from postoperative 3 month to 6 months
anterior opening size
Time Frame: Change from postoperative 1 month to 3 months
area,diameter
Change from postoperative 1 month to 3 months
anterior opening size
Time Frame: Change from postoperative 3 month to 6 months
area,diameter
Change from postoperative 3 month to 6 months
Stability of IOL
Time Frame: Change from postoperative 3 month to 6 months
Tilt and Decentration
Change from postoperative 3 month to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

yin ying zhao

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2015

Primary Completion (Actual)

July 1, 2015

Study Completion (Actual)

July 31, 2016

Study Registration Dates

First Submitted

February 25, 2017

First Submitted That Met QC Criteria

May 2, 2017

First Posted (Actual)

May 5, 2017

Study Record Updates

Last Update Posted (Actual)

May 5, 2017

Last Update Submitted That Met QC Criteria

May 2, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • kyk201601

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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