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

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ClinicalTrials.gov Identifier: NCT03142269
Recruitment Status : Completed
First Posted : May 5, 2017
Last Update Posted : May 5, 2017
Sponsor:
Information provided by (Responsible Party):
yin ying zhao, Wenzhou Medical University

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.

Condition or disease Intervention/treatment Phase
Myopia, High, With Cataract and Anterior Capsule Polished Procedure: 360°anterior capsule polishing Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Other
Official Title: The Influences of 360° Anterior Capsule Polishing on Refraction, Anterior Capsular Opening Size and IOL Stability Among Super High Myopia Patients
Actual Study Start Date : January 1, 2015
Actual Primary Completion Date : July 1, 2015
Actual Study Completion Date : July 31, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

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




Primary Outcome Measures :
  1. refraction [ Time Frame: Change from postoperative 1 day to 1 months ]
    refractive state

  2. anterior opening size [ Time Frame: Change from postoperative 1 day to 1 months ]
    area,diameter

  3. Stability of IOL [ Time Frame: Change from postoperative 1 months to 3 months ]
    Tilt and Decentration


Secondary Outcome Measures :
  1. refraction [ Time Frame: Change from postoperative 1 month to 3 months ]
    refractive state

  2. refraction [ Time Frame: Change from postoperative 3 month to 6 months ]
    refractive state

  3. anterior opening size [ Time Frame: Change from postoperative 1 month to 3 months ]
    area,diameter

  4. anterior opening size [ Time Frame: Change from postoperative 3 month to 6 months ]
    area,diameter

  5. Stability of IOL [ Time Frame: Change from postoperative 3 month to 6 months ]
    Tilt and Decentration



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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Responsible Party: yin ying zhao, doctor, Wenzhou Medical University
ClinicalTrials.gov Identifier: NCT03142269    
Other Study ID Numbers: kyk201601
First Posted: May 5, 2017    Key Record Dates
Last Update Posted: May 5, 2017
Last Verified: May 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cataract
Myopia
Lens Diseases
Eye Diseases
Refractive Errors