NCT02238015

Brief Summary

To compare tear film differences between surgical eyes and nonsurgical eyes in patients who had cataract surgery by phacoemulsification in one eye.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2013

Geographic Reach
1 country

1 active site

Status
unknown

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

October 1, 2013

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 28, 2014

Completed
15 days until next milestone

First Posted

Study publicly available on registry

September 12, 2014

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

September 12, 2014

Status Verified

September 1, 2014

Enrollment Period

7 months

First QC Date

August 28, 2014

Last Update Submit

September 11, 2014

Conditions

Cortical Senile Cataract

Keywords

cataract ,tear film,SS-OCT

Outcome Measures

Primary Outcomes (1)

  • Phacoemulsification influence on the postoperative tear functions

    1 year

Study Arms (2)

surgery group

patients underwent cataract surgery with 3.0 mm clear corneal incision at 11 o'clock in one eye

Procedure: cataract surgery

control group

patients' other eye that did not have surgery

Interventions

cataract surgeryPROCEDURE

All patients underwent cataract surgery with 3.0 mm clear corneal incision at 11 o'clock in one eye

surgery group

Eligibility Criteria

Age45 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

60 eyes from 30 age-related cataract participants underwent cataract surgery with 3.0 mm clear corneal incision at 11 o'clock in one eye and the other eye without surgery history

You may qualify if:

  • age-related cataract without surgery history and dry eye symptoms history

You may not qualify if:

  • diseases influencing tear secretion (such as Sjögren syndrome, Steve-Johnson syndrome, diabetes, thyroid disease, etc.); history of ocular surgeries or nuclear hardness IV and V, which required the use of larger phacoemulsification energy; use of drugs that affect tear secretion and stability (such as glaucoma medications, artificial tears, corticosteroid drugs, etc.); or presence of ocular diseases (such as Pterygium, blepharitis, uveitis, glaucoma, lacrimal apparatus, etc.).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wenzhou Medical University

Wenzhou, Zhejiang, 325027, China

RECRUITING

MeSH Terms

Interventions

Cataract Extraction

Intervention Hierarchy (Ancestors)

Refractive Surgical ProceduresOphthalmologic Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Qian Zheng, MD

    Wenzhou Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Qian Zheng, MD

CONTACT

18367839685zq15.04@163.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Wenzhou Medical University

Study Record Dates

First Submitted

August 28, 2014

First Posted

September 12, 2014

Study Start

October 1, 2013

Primary Completion

May 1, 2014

Study Completion

March 1, 2015

Last Updated

September 12, 2014

Record last verified: 2014-09

Locations

CN(1)