NCT03142269

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2015

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2016

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

February 25, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 5, 2017

Completed
Last Updated

May 5, 2017

Status Verified

May 1, 2017

Enrollment Period

6 months

First QC Date

February 25, 2017

Last Update Submit

May 2, 2017

Conditions

Myopia, High, With Cataract and Anterior Capsule Polished

Outcome Measures

Primary Outcomes (3)

  • refraction

    refractive state

    Change from postoperative 1 day to 1 months

  • anterior opening size

    area,diameter

    Change from postoperative 1 day to 1 months

  • Stability of IOL

    Tilt and Decentration

    Change from postoperative 1 months to 3 months

Secondary Outcomes (5)

  • refraction

    Change from postoperative 1 month to 3 months

  • refraction

    Change from postoperative 3 month to 6 months

  • anterior opening size

    Change from postoperative 1 month to 3 months

  • anterior opening size

    Change from postoperative 3 month to 6 months

  • Stability of IOL

    Change from postoperative 3 month to 6 months

Study Arms (2)

polished group

ACTIVE COMPARATOR

360°anterior capsule polishing was performed with double-ended capsule polisher randomly in one eye

Procedure: 360°anterior capsule polishing

unpolished group

PLACEBO COMPARATOR

the opposite unpolished was used as the control

Procedure: 360°anterior capsule polishing

Interventions

360°anterior capsule polishingPROCEDURE

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

polished groupunpolished group

Eligibility Criteria

Age50 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
doctor

Study Record Dates

First Submitted

February 25, 2017

First Posted

May 5, 2017

Study Start

January 1, 2015

Primary Completion

July 1, 2015

Study Completion

July 31, 2016

Last Updated

May 5, 2017

Record last verified: 2017-05