Pain Expression in the Perioperative Period of Cataract Surgery
2 other identifiers
interventional
150
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2013
CompletedFirst Submitted
Initial submission to the registry
April 2, 2013
CompletedFirst Posted
Study publicly available on registry
April 5, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2013
CompletedApril 5, 2013
April 1, 2013
4 months
April 2, 2013
April 4, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Post operative pain level
Post operative pain level recorded on a VAS (0-10) at rest for the first three days after cataract surgery.
3 days
Study Arms (3)
First eye (FE)
ACTIVE COMPARATORPhacoemulsification cataract extraction surgery of first eye
Second eye (SE)
ACTIVE COMPARATORPhacoemulsification cataract extraction surgery of second eye
Steroids eye drops
EXPERIMENTALDexamethasone eye drop, 1 drop, qid, for 3 days before surgery
Interventions
Phacoemulsification cataract extraction surgery
Phacoemulsification cataract extraction surgery
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Eye and ENT Hospital of Fudan University
Shanghai, Shanghai Municipality, 200031, China
Related Publications (1)
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.
PMID: 26305528DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Secretary of EBCS Group
Study Record Dates
First Submitted
April 2, 2013
First Posted
April 5, 2013
Study Start
January 1, 2013
Primary Completion
May 1, 2013
Last Updated
April 5, 2013
Record last verified: 2013-04