Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611001144909
Ethics application status
Approved
Date submitted
25/10/2011
Date registered
2/11/2011
Date last updated
7/11/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Advantages of Small Incision Pterygium (Surfer's Eye) Removal
Scientific title
Small incision Pterygium Removal Reduces Surgery Time and Pain, and Speeds Corneal Wound Healing
Secondary ID [1] 273269 0
Nil
Universal Trial Number (UTN)
U1111-1125-5418
Trial acronym
NA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pterygium 279034 0
Condition category
Condition code
Eye 279220 279220 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The new surgery protocol is characterized as having a small cut on the neck of pterygium body for conjunctiva separation before the head of pterygium is taken down, removing the head of pterygium by using a forceps, and loosening the corneal epithelia by local anesthesia (1-2 drops of Oxybuprocaine Hydrochloride Eye Drops, Santen Pharmaceutical Co., Ltd., Osaka, Japan). The averaged surgical time under the new protocol was approximately 8 minutes.
Intervention code [1] 269611 0
Treatment: Surgery
Comparator / control treatment
Conventional removal method firstly cuts down the head of pterygium before seperating the conjunctiva from underlying degenerated Tenon’s layer. In addition, the head of ptergium is cut down with scalpel instead of being pulled with a forceps. The averaged surgical duration under conventional protocol was approximately 15 minutes.
Control group
Active

Outcomes
Primary outcome [1] 279852 0
Shortened surgery time
Timepoint [1] 279852 0
On completion of surgery
Secondary outcome [1] 294580 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] 294580 0
3 days after the surgery
Secondary outcome [2] 294651 0
Quicker corneal wound healing. The corneal healing is indicated if a fluorescent staining is negative. A larger number of subjects with healed corneal was seen in the first and second days after the surgery in subjects receiving the new surgery.
Timepoint [2] 294651 0
3 days after the surgery

Eligibility
Key inclusion criteria
Subjects with primary pterygium without any other ocular pathologies
Minimum age
36 Years
Maximum age
74 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Subject with primary pterygium with any other ocular pathologies

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
1/01/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment outside Australia
Country [1] 3927 0
China
State/province [1] 3927 0
Jiang SU

Funding & Sponsors
Funding source category [1] 284098 0
Self funded/Unfunded
Name [1] 284098 0
Country [1] 284098 0
Primary sponsor type
Individual
Name
Shu Zhang
Address
No.121, Jiangjiayuan Road, Xiaguan District
Nanjing
210011
Country
China
Secondary sponsor category [1] 269060 0
Hospital
Name [1] 269060 0
The Second Affiliated Hospital of Nanjing Medical University
Address [1] 269060 0
No.121, Jiangjiayuan Road, Xiaguan District
Nanjing
210011
Country [1] 269060 0
China

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 272049 0
Approved by The Human Research Ethics Committee of the Second Affiliated Hospital of Nanjing Medical University
Ethics committee address [1] 272049 0
No.121, Jiangjiayuan Road, Xiaguan District
Nanjing
210011
Ethics committee country [1] 272049 0
China
Date submitted for ethics approval [1] 272049 0
20/12/2004
Approval date [1] 272049 0
31/12/2004
Ethics approval number [1] 272049 0

Summary
Brief summary
Totally 20 primary pterygium cases were engaged to have the pterygium removed with the improved removal surgery. The new surgery protocol is characterized as having a small cut on the neck of pterygium body for conjunctiva separation before the head of pterygium is taken down, removing the head of pterygium by using a forceps, and loosening the corneal epithelia by local anesthesia. 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 33309 0
Address 33309 0
Country 33309 0
Phone 33309 0
Fax 33309 0
Email 33309 0
Contact person for public queries
Name 16556 0
Dr Shu Zhang
Address 16556 0
No.121, Jiangjiayuan Road, Xiaguan District,
Nanjing
210011
China
Country 16556 0
China
Phone 16556 0
+86 25 58509913
Fax 16556 0
Email 16556 0
[email protected]
Contact person for scientific queries
Name 7484 0
Shu Zhang
Address 7484 0
Department of Ophthalmology, The Second Affiliated Hospital of Nanjing Medical University,
No.121, Jiangjiayuan Road, Xiaguan District, Nanjing, China, 210011
Country 7484 0
China
Phone 7484 0
+86 25 58509913
Fax 7484 0
Email 7484 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.