Pain Expression in the Perioperative Period of Cataract Surgery

April 4, 2013 updated by: Peng ZHOU, Evidence Based Cataract Study Group
Patients having cataract extraction in the second eye under topical anesthesia with monitored anesthesia care often report increased pain and awareness relative to the first surgery in the fellow eye, despite similar operative and anesthetic conditions. The purpose of this study is to investigate the pathogenesis of this phenomenon.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200031
        • Recruiting
        • Eye and ENT Hospital of Fudan University
        • Contact:
        • Principal Investigator:
          • Peng Zhou, M.D.
        • Sub-Investigator:
          • Xiang-Jia Zhu, M.D.
        • Sub-Investigator:
          • Ke-Ke Zhang, M.D.
        • Sub-Investigator:
          • Hong-Fei Ye, M.D.
        • Principal Investigator:
          • Yi Lu, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age-related cataract patients aged 50 years or older able to give informed consent undergoing cataract surgery;
  • Pupil dilation ≧7 mm after mydrisis;
  • VA prognosis ≧6/12

Exclusion Criteria:

  • Unable to give informed consent;
  • Patients with history of ocular pathology or diabetic retinopathy;
  • Patients with traumatic, subluxated and posterior polar cataract;
  • Patients had other ocular surgery (not cataract surgery) in the past 6 months;
  • Patients with significant intra-operative complications

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: First eye (FE)
Phacoemulsification cataract extraction surgery of first eye
Procedure: First eye (FE)
Phacoemulsification cataract extraction surgery
Drug: Steroids eye drops
Use steroids eye drops to decrease the pain.
Active Comparator: Second eye (SE)
Phacoemulsification cataract extraction surgery of second eye
Drug: Steroids eye drops
Use steroids eye drops to decrease the pain.
Procedure: Second eye (SE)
Phacoemulsification cataract extraction surgery
Experimental: Steroids eye drops
Dexamethasone eye drop, 1 drop, qid, for 3 days before surgery
Procedure: First eye (FE)
Phacoemulsification cataract extraction surgery
Procedure: Second eye (SE)
Phacoemulsification cataract extraction surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post operative pain level
Time Frame: 3 days
Post operative pain level recorded on a VAS (0-10) at rest for the first three days after cataract surgery.
3 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Evidence Based Cataract Study Group

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Anticipated)

May 1, 2013

Study Registration Dates

First Submitted

April 2, 2013

First Submitted That Met QC Criteria

April 4, 2013

First Posted (Estimate)

April 5, 2013

Study Record Updates

Last Update Posted (Estimate)

April 5, 2013

Last Update Submitted That Met QC Criteria

April 4, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EBCS001
  • NSFC81200669 (Other Grant/Funding Number: National Natural Science Foundation of China (NSFC, No. 81200669))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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