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Pain Expression in the Perioperative Period of Cataract Surgery

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2013 by Peng ZHOU, Evidence Based Cataract Study Group.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01824927
First Posted: April 5, 2013
Last Update Posted: April 5, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Peng ZHOU, Evidence Based Cataract Study Group
  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
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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 Peng ZHOU, Evidence Based Cataract Study Group:

Primary Outcome Measures:
  • 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.


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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   50 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 ( Other Grant/Funding Number: National Natural Science Foundation of China (NSFC, No. 81200669) )
First Submitted: April 2, 2013
First Posted: April 5, 2013
Last Update Posted: April 5, 2013
Last Verified: April 2013

Additional relevant MeSH terms:
Cataract
Eye Pain
Lens Diseases
Eye Diseases
Pain
Neurologic Manifestations
Nervous System Diseases
Eye Manifestations
Signs and Symptoms
Ophthalmic Solutions
Tetrahydrozoline
Pharmaceutical Solutions
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nasal Decongestants
Vasoconstrictor Agents
Respiratory System Agents