Pain Expression in the Perioperative Period of Cataract Surgery

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by Evidence Based Cataract Study Group
Sponsor:
Information provided by (Responsible Party):
Peng ZHOU, Evidence Based Cataract Study Group
ClinicalTrials.gov Identifier:
NCT01824927
First received: April 2, 2013
Last updated: April 4, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention
Cataract
Surgery
Eye Pain
Procedure: First eye (FE)
Procedure: Second eye (SE)
Drug: Steroids eye drops

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Supportive Care
Official Title: Pain Expression in the Perioperative Period of Cataract Surgery

Resource links provided by NLM:


Further study details as provided by Evidence Based Cataract Study Group:

Primary Outcome Measures:
  • Post operative pain level [ Time Frame: 3 days ] [ Designated as safety issue: No ]
    Post operative pain level recorded on a VAS (0-10) at rest for the first three days after cataract surgery.


Estimated Enrollment: 150
Study Start Date: January 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Procedure: Second eye (SE)
Phacoemulsification cataract extraction surgery
Drug: Steroids eye drops
Use steroids eye drops to decrease the pain.
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

  Eligibility

Ages Eligible for Study:   50 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01824927

Contacts
Contact: Peng ZHOU, M.D. +86-18801871108 drzhoupeng@gmail.com

Locations
China, Shanghai
Eye and ENT Hospital of Fudan University Recruiting
Shanghai, Shanghai, China, 200031
Contact: Peng Zhou, M.D.    +86-18801871108    drzhoupeng@gmail.com   
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.         
Sponsors and Collaborators
Evidence Based Cataract Study Group
  More Information

No publications provided

Responsible Party: Peng ZHOU, Secretary of EBCS Group, Evidence Based Cataract Study Group
ClinicalTrials.gov Identifier: NCT01824927     History of Changes
Other Study ID Numbers: EBCS001, NSFC81200669
Study First Received: April 2, 2013
Last Updated: April 4, 2013
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Cataract
Eye Pain
Lens Diseases
Eye Diseases
Eye Manifestations
Signs and Symptoms
Pain
Tetrahydrozoline
Nasal Decongestants
Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Respiratory System Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 26, 2014