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Pain Expression in the Perioperative Period of Cataract Surgery

Primary Purpose

Cataract, Surgery, Eye Pain

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

First eye (FE)

Second eye (SE)

Steroids eye drops

About this trial

This is an interventional supportive care trial for Cataract

Eligibility Criteria

50 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Eye and ENT Hospital of Fudan UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Arm Label

First eye (FE)

Second eye (SE)

Steroids eye drops

Arm Description

Phacoemulsification cataract extraction surgery of first eye

Phacoemulsification cataract extraction surgery of second eye

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

Outcomes

Primary Outcome Measures

Post operative pain level

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

Secondary Outcome Measures

Full Information

NCT ID

NCT01824927

First Posted

April 2, 2013

Last Updated

April 4, 2013

Sponsor

Evidence Based Cataract Study Group

1. Study Identification

Unique Protocol Identification Number

NCT01824927

Brief Title

Pain Expression in the Perioperative Period of Cataract Surgery

Official Title

Pain Expression in the Perioperative Period of Cataract Surgery

Study Type

Interventional

2. Study Status

Record Verification Date

April 2013

Overall Recruitment Status

Unknown status

Study Start Date

January 2013 (undefined)

Primary Completion Date

May 2013 (Anticipated)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Evidence Based Cataract Study Group

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cataract, Surgery, Eye Pain

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Non-Randomized

Enrollment

150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

First eye (FE)

Arm Type

Active Comparator

Arm Description

Phacoemulsification cataract extraction surgery of first eye

Arm Title

Second eye (SE)

Arm Type

Active Comparator

Arm Description

Phacoemulsification cataract extraction surgery of second eye

Arm Title

Steroids eye drops

Arm Type

Experimental

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

First eye (FE)

Intervention Description

Phacoemulsification cataract extraction surgery

Intervention Type

Procedure

Intervention Name(s)

Second eye (SE)

Intervention Description

Phacoemulsification cataract extraction surgery

Intervention Type

Drug

Intervention Name(s)

Steroids eye drops

Intervention Description

Use steroids eye drops to decrease the pain.

Primary Outcome Measure Information:

Title

Post operative pain level

Description

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

Time Frame

3 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Peng ZHOU, M.D.

Phone

+86-18801871108

drzhoupeng@gmail.com

Facility Information:

Facility Name

Eye and ENT Hospital of Fudan University

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200031

Country

China

Individual Site Status

Recruiting

Facility Contact: