Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12611000323921
Ethics application status
Approved
Date submitted
22/03/2011
Date registered
28/03/2011
Date last updated
18/04/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Pain during second eye cataract surgery under topical anesthesia: an intraindividual study
Scientific title
Pain during second eye cataract surgery under topical anesthesia: an intraindividual study
Secondary ID [1] 259830 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
pain during cataract surgery 265404 0
Condition category
Condition code
Eye 265564 265564 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Patients will be asked to grade pain experienced during both first and second eye cataract surgery under topical anesthesia, using a Visual Analog Scale. Difference in pain perception during first and second eye surgery will then be evaluated. Partecipants will be recruited over a period of 3 years, in order to reach a sample size of 60 patients for statistical evaluation. Allowing for possible drop-outs due to intraoperative events causing differences in surgical technique, at least 70 elegible patients will be recruited for the study
Intervention code [1] 264256 0
Not applicable
Comparator / control treatment
n/a
Control group
Uncontrolled

Outcomes
Primary outcome [1] 262368 0
Primary Outcome: Visual Analog Scale pain score after cataract procedure
Timepoint [1] 262368 0
Immediately after both first and second eye surgery. Time between first and second eye surgery may vary considerably, depending upon cataract evolution in each individual patient.
Secondary outcome [1] 273644 0
Secondary Outcome: subjective evaluation of difference in pain perception between first and second eye procedure. Patients will be asked at the end of surgery on the second eye if they had more pain during the first or the second procedure.
Timepoint [1] 273644 0
After second eye surgery

Eligibility
Key inclusion criteria
Patients undergoing bilateral non-simultaneous cataract surgery
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
secondary cataracts
ineligible for topical anesthesia
unilateral cataract

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
14/06/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
73
Accrual to date
Final
Recruitment outside Australia
Country [1] 3306 0
Italy
State/province [1] 3306 0

Funding & Sponsors
Funding source category [1] 264709 0
Self funded/Unfunded
Name [1] 264709 0
Country [1] 264709 0
Italy
Primary sponsor type
Individual
Name
Antonio Bardocci, MD
Address
Via Cecilio Stazio 39, Rome
Country
Italy
Secondary sponsor category [1] 263840 0
None
Name [1] 263840 0
Address [1] 263840 0
Country [1] 263840 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 266702 0
Comitato Etico Ospedale San Pietro - Fatebenefratelli
Ethics committee address [1] 266702 0
Via Cassia 600, Rome
Ethics committee country [1] 266702 0
Italy
Date submitted for ethics approval [1] 266702 0
29/05/2006
Approval date [1] 266702 0
Ethics approval number [1] 266702 0

Summary
Brief summary
Aim of the study was to investigate 1) if second eye cataract surgery under topical anesthesia is more painful than surgery on the first eye; 2) if pain experienced during the procedure on the first eye may predict the pain of the second procedure; 3) if patients' cooperation is different between the first and the second eye procedure.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32369 0
Address 32369 0
Country 32369 0
Phone 32369 0
Fax 32369 0
Email 32369 0
Contact person for public queries
Name 15616 0
Antonio Bardocci
Address 15616 0
Via Cecilio Stazio 39, Rome
Country 15616 0
Italy
Phone 15616 0
+393383047589
Fax 15616 0
Email 15616 0
[email protected]
Contact person for scientific queries
Name 6544 0
Antonio Bardocci
Address 6544 0
Via Cecilio Stazio 39, Rome
Country 6544 0
Italy
Phone 6544 0
+393383047589
Fax 6544 0
Email 6544 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.