Pain Expression in the Perioperative Period of Cataract Surgery

NCT ID: NCT01824927

Last Updated: 2013-04-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Brief Summary

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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

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Conditions

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Cataract Surgery Eye Pain

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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First eye (FE)

Phacoemulsification cataract extraction surgery of first eye

Group Type ACTIVE_COMPARATOR

First eye (FE)

Intervention Type PROCEDURE

Phacoemulsification cataract extraction surgery

Steroids eye drops

Intervention Type DRUG

Use steroids eye drops to decrease the pain.

Second eye (SE)

Phacoemulsification cataract extraction surgery of second eye

Group Type ACTIVE_COMPARATOR

Second eye (SE)

Intervention Type PROCEDURE

Phacoemulsification cataract extraction surgery

Steroids eye drops

Intervention Type DRUG

Use steroids eye drops to decrease the pain.

Steroids eye drops

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

Group Type EXPERIMENTAL

First eye (FE)

Intervention Type PROCEDURE

Phacoemulsification cataract extraction surgery

Second eye (SE)

Intervention Type PROCEDURE

Phacoemulsification cataract extraction surgery

Interventions

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First eye (FE)

Phacoemulsification cataract extraction surgery

Intervention Type PROCEDURE

Second eye (SE)

Phacoemulsification cataract extraction surgery

Intervention Type PROCEDURE

Steroids eye drops

Use steroids eye drops to decrease the pain.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Evidence Based Cataract Study Group

OTHER

Sponsor Role lead

Responsible Party

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Peng ZHOU

Secretary of EBCS Group

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Eye and ENT Hospital of Fudan University

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Peng ZHOU, M.D.

Role: CONTACT

+86-18801871108

Facility Contacts

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Peng Zhou, M.D.

Role: primary

+86-18801871108

References

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Zhu XJ, Wolff D, Zhang KK, He WW, Sun XH, Lu Y, Zhou P. Molecular Inflammation in the Contralateral Eye After Cataract Surgery in the First Eye. Invest Ophthalmol Vis Sci. 2015 Aug;56(9):5566-73. doi: 10.1167/iovs.15-16531.

Reference Type DERIVED
PMID: 26305528 (View on PubMed)

Other Identifiers

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NSFC81200669

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

EBCS001

Identifier Type: -

Identifier Source: org_study_id

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