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Trial registered on ANZCTR


Registration number
ACTRN12611001211954
Ethics application status
Approved
Date submitted
20/11/2011
Date registered
24/11/2011
Date last updated
28/11/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Using Forceps to Remove the Rusty Ring that Forms after a Metal Foreign Body in the Cornea
Scientific title
Cornea Rusty Ring Removal by Forceps Reduces Surgery Time and Pain, and Speeds Corneal Wound Healing
Secondary ID [1] 273414 0
Nil
Universal Trial Number (UTN)
U1111-1125-9497
Trial acronym
NA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cornea Foreign Body 279206 0
Condition category
Condition code
Eye 279411 279411 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In the conventional protocol, the residual material after foreign body is taken off and rusty ring are digged out by using a 30G injection syringe needle.
In the new protocol, the rusty ring is removed mainly by using a micro-knot forceps which is usually used in the anterior eye segment surgery. The rim of the ringelevated slightly by the needle tip so that it could be grasped easily with the forceps. Then, the entire ring was pulled gently using the forceps. The average surgery time under the new protocol was 3.2 min.
Intervention code [1] 283750 0
Treatment: Surgery
Comparator / control treatment
The residual material and rusty ring were removed using the needle alone. Several trials of digging were usually required to remove pieces of the ring one after another until the entire ring was removed. The average surgery timeunder conventional protocol was 5.1 min.
Control group
Active

Outcomes
Primary outcome [1] 285983 0
Shortened surgery time
Timepoint [1] 285983 0
On completion of surgery
Secondary outcome [1] 294895 0
reduced pain score as quantified in a 4-point scale (0=none; 1=little; 2=some; 3=much) reported by the patients
Timepoint [1] 294895 0
3 days after the surgery
Secondary outcome [2] 294896 0
Quicker corneal wound healing, which is indicated if fluorescent staining against damaged corneal epithelium is negative. The staining is examined with a micro-slit lamp (Haag-Streit 900, Gartenstadtstrasse, Switzerland) 24, 48, and 72 h after the surgery, with a blue light illumination.
A larger number of subjects with healed corneal is seen in the first and second days after the surgery in subjects receiving the new surgery.
Timepoint [2] 294896 0
1,2 and 3 days after the surgery

Eligibility
Key inclusion criteria
Subjects with superficial corneal foreign body injuries caused by metal debris (one eye in each patient)
Minimum age
18 Years
Maximum age
56 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
If removal was complete with no rusty ring remaining after a levering action was used by a needle to remove the foreign body from the cornea.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The subjects are refered by clinicians in the department, who do not know which group the subject will be allocated. At this stage, allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The subjects are numbered according the time sequence of the refereral. A simple randomisation table from a statistic book is used to allocate the subjects.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 3968 0
China
State/province [1] 3968 0
Jiangsu

Funding & Sponsors
Funding source category [1] 284231 0
Self funded/Unfunded
Name [1] 284231 0
Address [1] 284231 0
Country [1] 284231 0
Primary sponsor type
Individual
Name
Shu Zhang
Address
No.121, Jiangjiayuan Road, Xiaguan District
Nanjing
210011
Country
China
Secondary sponsor category [1] 269186 0
Hospital
Name [1] 269186 0
The Second Affiliated Hospital of Nanjing Medical University
Address [1] 269186 0
No.121, Jiangjiayuan Road, Xiaguan District
Nanjing
210011
Country [1] 269186 0
China

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286194 0
The Human Research Ethics Committee of the Second Affiliated
Ethics committee address [1] 286194 0
No.121, Jiangjiayuan Road, Xiaguan District
Nanjing
210011
Ethics committee country [1] 286194 0
China
Date submitted for ethics approval [1] 286194 0
10/12/2009
Approval date [1] 286194 0
20/12/2009
Ethics approval number [1] 286194 0

Summary
Brief summary
Totally 40 cornea metal foreign body injury cases were engaged to have the foreign body removal surgery. The new surgery protocol is characterized as a levering action was used to remove the foreign body from the cornea. If removal was incomplete due to the remaining of a rusty ring, removing the rim of the ring was elevated slightly by the needle tip so that it could be grasped easily with the forceps. Then, the entire ring was pulled gently using the forceps. The advantages of the new surgery include shortened surgery time, reduced pain score, and shortened corneal wound healing.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33411 0
Address 33411 0
Country 33411 0
Phone 33411 0
Fax 33411 0
Email 33411 0
Contact person for public queries
Name 16658 0
Shu Zhang
Address 16658 0
No.121, Jiangjiayuan Road, Xiaguan District,
Nanjing
210011
Country 16658 0
China
Phone 16658 0
+86 25 58509913
Fax 16658 0
Email 16658 0
zhangs60@yahoo.com.cn
Contact person for scientific queries
Name 7586 0
Shu Zhang
Address 7586 0
No.121, Jiangjiayuan Road, Xiaguan District,
Nanjing
210011
Country 7586 0
China
Phone 7586 0
+86 25 58509913
Fax 7586 0
Email 7586 0
zhangs60@yahoo.com.cn

No data has been provided for results reporting
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary