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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03142269
Other study ID # kyk201601
Secondary ID
Status Completed
Phase N/A
First received February 25, 2017
Last updated May 2, 2017
Start date January 1, 2015
Est. completion date July 31, 2016

Study information

Verified date May 2017
Source Wenzhou Medical University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date July 31, 2016
Est. primary completion date July 1, 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 50 Years to 70 Years
Eligibility 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 Design


Related Conditions & MeSH terms

  • Cataract
  • Myopia
  • Myopia, High, With Cataract and Anterior Capsule Polished

Intervention

Procedure:
360°anterior capsule polishing
360°anterior capsule polishing was performed with double-ended capsule polisher

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
yin ying zhao

Outcome

Type Measure Description Time frame Safety issue
Primary refraction refractive state Change from postoperative 1 day to 1 months
Primary anterior opening size area,diameter Change from postoperative 1 day to 1 months
Primary Stability of IOL Tilt and Decentration Change from postoperative 1 months to 3 months
Secondary refraction refractive state Change from postoperative 1 month to 3 months
Secondary refraction refractive state Change from postoperative 3 month to 6 months
Secondary anterior opening size area,diameter Change from postoperative 1 month to 3 months
Secondary anterior opening size area,diameter Change from postoperative 3 month to 6 months
Secondary Stability of IOL Tilt and Decentration Change from postoperative 3 month to 6 months