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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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CTRI |
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Last refreshed on:
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24 November 2021 |
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Main ID: |
CTRI/2015/07/005960 |
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Date of registration:
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03-07-2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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To compare which type of sugery is better for treatment of pterygium
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Scientific title:
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Comparative outcome of Conjunctival autograft and Amniotic membrane transplantation following double pterygium excision in the same eye |
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Date of first enrolment:
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05-04-2011 |
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Target sample size:
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31 |
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Recruitment status: |
Completed |
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URL:
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http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=10669 |
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Study type:
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Interventional |
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Study design:
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Randomized, Parallel Group, Active Controlled Trial
Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:On-site computer system Blinding and masking:Participant, Investigator and Outcome Assessor Blinded
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Phase:
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N/A
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Countries of recruitment
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India
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Contacts
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Name:
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Venkatesh Prajna
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Address:
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1,Anna Nagar,Aravind eye hospital,Madurai,Tamil Nadu,India 1,Anna nagar,Aravind eye hospital.
625020
Madurai, TAMIL NADU
India |
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Telephone:
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04524356550 |
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Email:
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prajna@aravind.org |
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Affiliation:
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Aravind eye hospital |
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Name:
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Venkatesh Prajna
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Address:
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1,Anna Nagar,Aravind eye hospital,Madurai,Tamil Nadu,India 1,Anna nagar,Aravind eye hospital.
625020
Madurai, TAMIL NADU
India |
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Telephone:
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04524356550 |
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Email:
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prajna@aravind.org |
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Affiliation:
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Aravind eye hospital |
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Key inclusion & exclusion criteria
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Inclusion criteria: age more than 18 years
primary double pterygium with operable features
Exclusion criteria: children below the age of 18 years
previous history of trauma or chemical injury
pregnancy
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Health Condition 1: null- Double pterygium
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Intervention(s)
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Control Intervention1: conjunctival autograft: The tissue which is taken from patients own superior bulbar conjunctiva and tranplanted at the excised site
Control Intervention2: amniotic membrane graft: Tissue which is prepared from human placenta and processed and preserved placed at the excision site.Since this is not a drug there is no dosage schedule and its done only once.
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Primary Outcome(s)
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To assess the recuurence of pterygium nasally and temporally after double pterygium excision when replaced with conjunctival autograft and amniotic graft randomlyTimepoint: 0-1 year
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Secondary Outcome(s)
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To assess whether site of replacement of the conjunctival autograft and amniotic membrane graft plays a role in recurrenceTimepoint: 0-1 year
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Source(s) of Monetary Support
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Self funded
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Ethics review
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Status: Approved
Approval date: 25/03/2011
Contact:
Aravind eye care system intitutional review board
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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