Pain Expression in the Perioperative Period of Cataract Surgery

Not Applicable

• Conditions: Eye Pain; Cataract; Surgery
• Interventions: Procedure: First eye (FE); Procedure: Second eye (SE); Drug: Steroids eye drops

• Registration Number: NCT01824927
• Lead Sponsor: Evidence Based Cataract Study Group

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01
• Status Verified: 2013-04
• Study First Submitted: 2013-04-02
• Study First Submitted QC: 2013-04-04
• Last Update Submitted: 2013-04-04
• Study First Posted: 2013-04-05
• Last Update Posted: 2013-04-05
• Primary Completion: 2013-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Steroids eye drops	Second eye (SE)	Dexamethasone eye drop, 1 drop, qid, for 3 days before surgery
First eye (FE)	Steroids eye drops	Phacoemulsification cataract extraction surgery of first eye
First eye (FE)	First eye (FE)	Phacoemulsification cataract extraction surgery of first eye
Second eye (SE)	Steroids eye drops	Phacoemulsification cataract extraction surgery of second eye
Second eye (SE)	Second eye (SE)	Phacoemulsification cataract extraction surgery of second eye
Steroids eye drops	First eye (FE)	Dexamethasone eye drop, 1 drop, qid, for 3 days before surgery

Primary Outcome Measures

Name	Time	Method
Post operative pain level	3 days	Post operative pain level recorded on a VAS (0-10) at rest for the first three days after cataract surgery.

Trial Locations

Locations (1)

Eye and ENT Hospital of Fudan University; 🇨🇳 Shanghai, Shanghai, China