NCT02026765

Brief Summary

The purpose of this study is to obverse the effect of this type lens in the same as traditional aspheric intraocular lens at the same time, whether can further improve the effects of operation.

Trial Health

87
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 Nov 2013

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 17, 2013

Completed
17 days until next milestone

First Posted

Study publicly available on registry

January 3, 2014

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

December 9, 2015

Status Verified

December 1, 2015

Enrollment Period

11 months

First QC Date

December 17, 2013

Last Update Submit

December 8, 2015

Conditions

Inflammatory Reaction

Outcome Measures

Primary Outcomes (1)

  • flare value in the anterior chamber after surgery

    use Laser Flare Meter to measure the flare in the anterior chamber to evaluate postoperative ocular inflammatory reaction

    six months

Secondary Outcomes (1)

  • the ocular and the anterior corneal aberration after surgery

    six months

Study Arms (2)

Heparin Surface Modified Aspheric Lens

OTHER

Heparin Surface Modified Aspheric Lens

Device: heparin surface modified aspheric lens

traditional lens

OTHER

traditional Aspheric lens

Device: traditional lens

Interventions

traditional lensDEVICE

A random eyes with traditional lens

traditional lens
heparin surface modified aspheric lensDEVICE

the other eye implant heparin surface modified aspheric lens

Heparin Surface Modified Aspheric Lens

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Cataract patients

You may not qualify if:

  • Eyed patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Affiliated Eye hospital of Wenzhou Medical University

Wenzhou, Zhejiang, 325000, China

Location

MeSH Terms

Conditions

Inflammation

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • AYong Yu, MD. PhD.

    Wenzhou Medical University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

December 17, 2013

First Posted

January 3, 2014

Study Start

November 1, 2013

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

December 9, 2015

Record last verified: 2015-12

Locations

CN(1)