Pain Expression in the Perioperative Period of Cataract Surgery

Surgery Clinical Trial

Official title:

Pain Expression in the Perioperative Period of Cataract Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01824927
• Other study ID #: EBCS001
• Secondary ID: NSFC81200669
• Status: Recruiting
• Phase: N/A
• First received: April 2, 2013
• Last updated: April 4, 2013
• Start date: January 2013

Study information

• Verified date: April 2013
• Source: Evidence Based Cataract Study Group
• Contact: Peng ZHOU, M.D.
• Phone: +86-18801871108
• Email: drzhoupeng[@]gmail.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 85 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Cataract
• Eye Pain
• Surgery

Intervention

Procedure:
• First eye (FE)
Phacoemulsification cataract extraction surgery
• Second eye (SE)
Phacoemulsification cataract extraction surgery

Drug:
• Steroids eye drops
Use steroids eye drops to decrease the pain.

Locations

Country	Name	City	State
China	Eye and ENT Hospital of Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Evidence Based Cataract Study Group

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post operative pain level	Post operative pain level recorded on a VAS (0-10) at rest for the first three days after cataract surgery.	3 days	No