NCT01554761

Brief Summary

This study is to evaluate the necessity of considering posterior corneal toricity on refractive outcome of patients with cataracts and corneal astigmatism after implantation of intraocular lenses. This is determined by comparing total corneal and refractive astigmatism,and by comparing the expected refractive result with actual refractive astigmatism postoperatively,using total corneal and anterior corneal astigmatism to calculate respectively.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for phase_4

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

February 1, 2012

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

February 27, 2012

Completed
17 days until next milestone

First Posted

Study publicly available on registry

March 15, 2012

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
Last Updated

March 15, 2012

Status Verified

March 1, 2012

Enrollment Period

3 months

First QC Date

February 27, 2012

Last Update Submit

March 13, 2012

Conditions

AstigmatismCataract

Keywords

astigmatismpseudophakia

Outcome Measures

Primary Outcomes (2)

  • Pentacam-derived corneal astigmatism

    3month postoperatively

  • refraction

    3month postoperatively

Interventions

phacoemulsificationPROCEDURE

After topical anesthesia with Alcaine, 3.0-mm clear corneal incisions were made. Torsional phacoemulsification was performed using the Infiniti Vision System with the OZil handpiece, a 45-degree Kelman miniflared tip, and DuoVisc viscoelastic (all from Alcon).

Pentacam (Oculus,Germany)examinationDEVICE

Total corneal astigmatism is obtained by Pentacam at every visit.

Eligibility Criteria

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

You may qualify if:

  • cataract candidates
  • preoperative corneal regular astigmatism \>0.75D
  • Willing and able to complete all required postoperative visits
  • Able to comprehend and sign a statement of informed consent

You may not qualify if:

  • significant intraocular lenses tilt or decentration
  • corneal scarring
  • Irregular corneal astigmatism
  • other ocular diseases
  • surgical complication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eye hospital of China Medical Univerisity

Shenyang, Liaoning, 110005, China

RECRUITING

MeSH Terms

Conditions

AstigmatismCataractPseudophakia

Interventions

Phacoemulsification

Condition Hierarchy (Ancestors)

Refractive ErrorsEye DiseasesLens DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cataract ExtractionRefractive Surgical ProceduresOphthalmologic Surgical ProceduresSurgical Procedures, OperativeUltrasonic Surgical Procedures

Study Officials

  • Jinsong Zhang, MD

    Eye Hospital of China Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Qi Sun, MD

CONTACT

+86 15840336028qisun97@sina.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD,the President of Eye hosptial of China Medical Univerisity,China

Study Record Dates

First Submitted

February 27, 2012

First Posted

March 15, 2012

Study Start

February 1, 2012

Primary Completion

May 1, 2012

Last Updated

March 15, 2012

Record last verified: 2012-03

Locations

CN(1)