Protocol summary

Summary
Pterygium is a wing‑shape fibrovascular lesion of the ocular surface, which is associated with chronic sunlight exposure. As pterygium progress, decreased vision, discomfort and restricted ocular motility can result. Until now, a wide spectrum of treatment strategies have been described for pterygium treatment, including pterygium excision with bare sclera, conjunctival autograft, amniotic membrane transplantation (AMT), adjunctive use of mitomycin‑C. Pterygium excision followed by conjunctival autograft has been shown to be a safe and effective procedure for pterygium, with recurrence rates ranging from 2% to 39%. Various suture materials and techniques are employed to secure the autograft, including absorbable and non-absorbable sutures of different diameters. A prospective, randomized, controlled, clinical trial will conducted, in which 50 eyes of 50 patients with primary nasal pterygium will randomized to undergo pterygium surgery with the use of nylon sutures or silk sutures for conjunctival autograft suturing. Patients will followed up for 6 months. Outcome measures included postoperative discomfort according to a visual analogue scale (VAS), graft dehiscence, graft edema, suture loosening and recurrence. All remaining sutures will removed 2 weeks postoperatively.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016100230080N1
Registration date: 2017-01-13, 1395/10/24
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-01-13, 1395/10/24
Registrant information
Name
Hossein Jamali
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3230 2830
Email address
jamaliho@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Shiraz University of Medical Sciences
Expected recruitment start date
2015-12-22, 1394/10/01
Expected recruitment end date
2016-03-19, 1394/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical outcomes of silk sutures versus nylon sutures for suturing of conjunctival autograft in pterygium surgery
Public title
Clinical outcomes of silk sutures versus nylon sutures for suturing of conjunctival autograft in pterygium surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: primary nasal pterygium; age 18 years or older and able to co-operate in surgery under local anesthesia Exclusion criteria: recurrent pterygium, temporal or double-head pterygia, scarred superior conjunctiva, previous surgery involving the superior bulbar conjunctiva, history of glaucoma, and⁄or cicatricial ocular surface disease
Age
From 18 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Shiraz University of Medical Sciences
Street address
Khalili Hospital, Khalili Street, Shiraz
City
Shiraz
Postal code
7134997446
Approval date
2015-12-07, 1394/09/16
Ethics committee reference number
IR.SUMS.MED.REC.1394.59

Health conditions studied

1

Description of health condition studied
Pterygium
ICD-10 code
H11.0
ICD-10 code description
Pterygium

Primary outcomes

1

Description
Difference in VAS score between the two groups
Timepoint
One day after surgery and one week after surgery and two weeks after surgery
Method of measurement
Visual analogue scale

Secondary outcomes

1

Description
Graft hyperaemia, graft dehiscence, graft edema, suture loosening and recurrence
Timepoint
First day and first week and first month and third and sixth months after surgery
Method of measurement
Clinical examination and slit photography

Intervention groups

1

Description
Silk sutures in intervention group for suturing of autograft conjunctival tissue and will remain for two weeks in the patient's eye
Category
Treatment - Surgery

2

Description
Nylon sutures in intervention group for suturing of autograft conjunctival tissue and will remain for two weeks in the patient's eye
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
Khalili Hospital
Full name of responsible person
Doctor Hossein Jamali
Street address
Khalili Hospital, Khalili Street, Shiraz
City
Shiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellorfor research, Shiraz University of Medical Sciences
Full name of responsible person
Doctor Seyed Basir Hashemi
Street address
Shiraz University of Medical Sciences central building, Zand BLVD, Shiraz, Iran
City
Shiraz
Grant name
پایان نامه دانشجویی
Grant code / Reference number
94-01-01-9194
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellorfor research, Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Doctor Hossein Jamali
Position
Anterior Segment Fellowship
Other areas of specialty/work
Street address
Shiraz University of Medical Sciences central building, Zand BLVD, Shiraz, Iran
City
Shiraz
Postal code
7134814336
Phone
+98 71 3230 5410
Fax
+98 71 3233 7598
Email
jamali.md_ophthl@yahoo.com; jamaliho@sums.ac.ir
Web page address
Psorc.sums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Doctor Hossein Jamali
Position
Anterior Segment Fellowship
Other areas of specialty/work
Street address
Shiraz University of Medical Sciences central building, Zand BLVD, Shiraz, Iran
City
Shiraz
Postal code
7134997446
Phone
+98 71 3230 5410
Fax
+98 71 3233 7598
Email
jamali.md_ophthal@yahoo.com; jamaliho@sums.ac.ir
Web page address
Psorc.sums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Doctor Hossein Jamali
Position
Anterior Segment Fellowship
Other areas of specialty/work
Street address
Shiraz University of Medical Sciences central building, Zand BLVD, Shiraz, Iran
City
Shiraz
Postal code
7134997446
Phone
+98 71 3230 5410
Fax
+98 71 3233 7598
Email
jamali.md_ophthal@yahoo.com; jamaliho@sums.ac.ir
Web page address
Psorc.sums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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