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


Trial ID
ACTRN12613000986774
Ethics application status
Not yet submitted
Date submitted
2/09/2013
Date registered
4/09/2013
Date last updated
4/09/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Prospective evaluation of pterygium excision and conjunctival autograft with autologous blood, fibrin glue, or vicryl sutures
Scientific title
Comparison of autologous blood versus fibrin glue versus vicryl sutures for conjunctival autografts in pterygium surgery, evaluating pain scores, graft stability, and recurrence in healthy adult patients.
Secondary ID [1] 283123 0
Nil
Universal Trial Number (UTN)
U1111-1147-4871
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pterygium 289973 0
Condition category
Condition code
Surgery 290344 290344 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Excision with conjunctival autograft involves removal of the pterygium leaving an area of bare sclera, which is closed by the movement of a free conjunctival transplant from another part of the ocular surface. The conjunctival autograft will be attached with autologous blood acting as a bioadhesive. The surgical intervention takes approximately 30 minutes and patients will be followed at 1 day, 1 week, 1 month, 3 months, 6 months, and 1 year.
Intervention code [1] 287843 0
Treatment: Surgery
Comparator / control treatment
There will be 2 comparator groups. One group of participants will have the conjunctival autograft attached with vicryl sutures and another group will have the conjunctival autograft attached with fibrin glue.
Control group
Active

Outcomes
Primary outcome [1] 290375 0
Graft stability will be assessed on a slit lamp exam, grading stability based on the number of adherent edges.
Timepoint [1] 290375 0
3 months from completion of surgery
Secondary outcome [1] 304373 0
Postoperative pain will be assessed based on a 0 (no pain) to 10 (worst pain in life) scale.
Timepoint [1] 304373 0
1 day and 1 week from completion of surgery.
Secondary outcome [2] 304374 0
Pterygium recurrence will be assessed on a slit lamp exam.
Timepoint [2] 304374 0
1 year from completion of surgery.

Eligibility
Key inclusion criteria
Age of patient should be more than 18 years.
Primary nasal pterygium.
Patient willing to be enrolled in the study and available for all subsequent follow-ups.
Minimum age
18 Years
Maximum age
90 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Age of patient less than 18 years
Recurrent pterygium (history of previous pterygium excision)
Temporal pterygium
Pterygium >4mm
Double headed primary pterygium (arising from both medial and lateral side of cornea)
Any previous ocular surface surgery
Patient unwilling to participate in the study and all required follow-ups

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint(s)
Statistical methods / analysis
Statistical assumptions based on researchers experience have been used. Patients with vicryl sutures tend to have more postoperative pain (5/10) compared to those with fibrin glue or autologous blood (1-2/10). Sample size calculations were completed based on these assumptions and 30 patients in each group was determined to be suffient to show a statistical difference with 80% power and 95% confidence level.

Recruitment
Recruitment status
Not yet recruiting
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 in Australia
Recruitment state(s)
VIC
Recruitment outside Australia
Country [1] 5350 0
India
State/province [1] 5350 0
Country [2] 5351 0
Hong Kong
State/province [2] 5351 0

Funding & Sponsors
Funding source category [1] 287873 0
Hospital
Name [1] 287873 0
Royal Victorian Eye and Ear Hospital
Address [1] 287873 0
32 Gisborne Street
East Melbourne, VIC 3002
Country [1] 287873 0
Australia
Primary sponsor type
Individual
Name
Ross MacIntyre
Address
Royal Victorian Eye and Ear Hospital
32 Gisborne Street
East Melbourne, VIC 3002
Country
Australia
Secondary sponsor category [1] 286600 0
Individual
Name [1] 286600 0
Rasik Vajpayee
Address [1] 286600 0
Royal Victorian Eye and Ear Hospital
32 Gisborne Street
East Melbourne, VIC 3002
Country [1] 286600 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 289816 0
Royal Victorian Eye and Ear Hospital Human Research and Ethics Committee
Ethics committee address [1] 289816 0
32 Gisborne Street
East Melbourne, VIC 3002
Ethics committee country [1] 289816 0
Australia
Date submitted for ethics approval [1] 289816 0
27/09/2013
Approval date [1] 289816 0
Ethics approval number [1] 289816 0

Summary
Brief summary
Our aim is to study the efficacy of pterygium excision and conjunctival autograft with autologous blood and compare with the gold standards of sutured autograft and autograft with fibrin glue. Conjunctival autografts with autologous blood have been reported to be effective in the literature. Only a small number of prospective studies with small numbers of patients have studied conjunctival autografts with autologous blood. Comparing this method to that with sutures and with fibrin glue will provide meaningful comparative data on efficacy of method, rates of recurrence, cost and patient comfort. We hypothesize that patients will experience less discomfort and will have similar rates of graft stability and recurrence.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 42570 0
Dr Ross MacIntyre
Address 42570 0
Royal Victorian Eye and Ear Hospital
32 Gisborne Street
East Melbourne, VIC 3002
Country 42570 0
Australia
Phone 42570 0
+61 3 9929 8666
Fax 42570 0
Email 42570 0
ross.macintyre@eyeandear.org.au
Contact person for public queries
Name 42571 0
Dr Ross MacIntyre
Address 42571 0
Royal Victorian Eye and Ear Hospital
32 Gisborne Street
East Melbourne, VIC 3002
Country 42571 0
Australia
Phone 42571 0
+61 3 9929 8666
Fax 42571 0
Email 42571 0
ross.macintyre@eyeandear.org.au
Contact person for scientific queries
Name 42572 0
Dr Ross MacIntyre
Address 42572 0
Royal Victorian Eye and Ear Hospital
32 Gisborne Street
East Melbourne, VIC 3002
Country 42572 0
Australia
Phone 42572 0
+61 3 9929 8666
Fax 42572 0
Email 42572 0
ross.macintyre@eyeandear.org.au