Pain Expression in the Perioperative Period of Cataract Surgery

Evidence Based Cataract Study Group

Status: Unknown

Conditions: Cataract; Surgery; Eye Pain

Treatments: Procedure: Second eye (SE); Procedure: First eye (FE); Drug: Steroids eye drops

Study type: Interventional

Funder types: Other

Identifiers

NCT01824927

NSFC81200669 (Other Grant/Funding Number)

EBCS001

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 50 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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150 participants in 3 patient groups

First eye (FE)

Active Comparator group

Description:

Phacoemulsification cataract extraction surgery of first eye

Treatment:

Drug: Steroids eye drops

Procedure: First eye (FE)

Second eye (SE)

Active Comparator group

Description:

Phacoemulsification cataract extraction surgery of second eye

Treatment:

Drug: Steroids eye drops

Procedure: Second eye (SE)

Steroids eye drops

Experimental group

Description:

Dexamethasone eye drop, 1 drop, qid, for 3 days before surgery

Treatment:

Procedure: First eye (FE)

Procedure: Second eye (SE)