Suspended

Pain Expression in the Perioperative Period of Cataract Surgery

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

First eye (FE)

+ Steroids eye drops

+ Second eye (SE)

ProcedureDrug
Who is being recruted

Eye Diseases+6

+ Eye Manifestations

+ Lens Diseases

From 50 to 85 Years
+8 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Supportive Care Study

Interventional
Study Start: January 2013
See protocol details

Summary

Principal SponsorEvidence Based Cataract Study Group
Study ContactPeng ZHOU, M.D.More contacts
Last updated: April 5, 2013
Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 2013

Actual date on which the first participant was enrolled.

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.

NCT01824927
Principal SponsorEvidence Based Cataract Study Group
Study ContactPeng ZHOU, M.D.More contacts
Last updated: April 5, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

150 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Supportive Care Study

These studies explore ways to improve comfort and daily life for people living with a condition. They may focus on easing symptoms, reducing treatment side effects, or supporting overall well-being.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 50 to 85 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Eye DiseasesEye ManifestationsLens DiseasesNeurologic ManifestationsPainSigns and SymptomsPathological Conditions, Signs and SymptomsCataractEye Pain

Criteria

3 inclusion criteria required to participate
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
5 exclusion criteria prevent from participating
Patients had other ocular surgery (not cataract surgery) in the past 6 months
Patients with history of ocular pathology or diabetic retinopathy
Patients with significant intra-operative complications
Patients with traumatic, subluxated and posterior polar cataract
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Active Comparator
Phacoemulsification cataract extraction surgery of first eye

Group II

Active Comparator
Phacoemulsification cataract extraction surgery of second eye

Group III

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

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Eye and ENT Hospital of Fudan University

Shanghai, ChinaOpen Eye and ENT Hospital of Fudan University in Google Maps
SuspendedOne Study Center