NCT02238002

Brief Summary

To investigate changes in anterior chamber angle configuration after phacoemulsification and intraocular lens (IOL) implantation with Swept-Source Optical Coherence Tomography (SS-OCT).

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
64

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2013

Completed
5 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

5 months

First QC Date

August 28, 2014

Last Update Submit

September 11, 2014

Conditions

CataractShallow Anterior ChamberNarrow Angle

Keywords

shallow anterior chambernarrow angleSS-OCT

Outcome Measures

Primary Outcomes (1)

  • anterior chamber angle parameters increased

    1 year

Study Arms (2)

normal angle

normal anterior chamber and open angle eyes underwent cataract surgery

Procedure: cataract surgery

narrow angle

shallow anterior chamber and narrow angle eyes underwent cataract surgery

Procedure: cataract surgery

Interventions

cataract surgeryPROCEDURE

The patients of both groups underwent cataract surgery

narrow anglenormal angle

Eligibility Criteria

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

patients who underwent phacoemulsification surgery in Eye Hospital of Wenzhou Medical University

You may qualify if:

  • ACD was less than 2.68mm. the anterior chamber angle width on gonioscopy≤Shaffer 2 .

You may not qualify if:

  • primary or secondary glaucoma, peripheral anterior synechiae, history of ocular surgeries

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eye Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, 325027, China

RECRUITING

MeSH Terms

Conditions

Cataract

Interventions

Cataract Extraction

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Refractive Surgical ProceduresOphthalmologic Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Yun e Zhao, MD

    Wenzhou Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Qian Zheng, MD

CONTACT

18367839685zq15.04@163.com

Study Design

Study Type
observational
Observational Model
COHORT
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

December 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)