cut, trim and paste-a new surgical approach to new fibrovascular growth on the cornea(primary pterygium)

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2014/12/005251
• Date of registration: 04-12-2014
• Prospective Registration: No
• Primary sponsor: karnataka institute of medical sciences
• Public title: cut, trim and paste-a new surgical approach to new fibrovascular growth on the cornea(primary pterygium)
• Scientific title: Use of superficial conjunctiva of the primary pterygium after excision as autograft at the site of primary pterygium with autologous fibrin - CTP
• Date of first enrolment: 02-12-2013
• Target sample size: 25
• Recruitment status: Completed
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=8871
• Study type: Interventional
• Study design: Single Arm Trial; Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable
• Phase: N/A

Countries of recruitment

India

Contacts

• Name: Dr Satish D Shet
• Affiliation: KIMS

• Name: Dr Satish D Shet
• Affiliation: KIMS

Key inclusion & exclusion criteria

Inclusion criteria: patients with primary pterygium > 1mm onto cornea
Exclusion criteria: ocular suface disorders like dry eyes, meibomian gland dysfunction,lagophthalmos

Major systemic diseases like collagen vascular disorders and uncontrolled diabetes mellitus

Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Health Condition 1: null- patients with primary pterygium

Intervention(s)

Intervention1: surgical procedure,no drugs: use of superficial conjunctiva of primary pterygium as conjunctival autograft with autologous fibrin without fibrin glue or sutures
Intervention2: pterygium surgery using superficial conjunctiva overlying pterygium as conjunctival autograft compared with surgery with conjuctival autograft, no drugs: surgical management of primary pterygium, without sutures,without fibrin glue, using superficial conjunctiva as conjunctival autograft without conjunctival autograft from a normal site
compared with surgical management of primary pterygium without sutures, without fibrin glue,with conjunctival autograft

Primary Outcome(s)

graft dislocation and pterygium recurrenceTimepoint: NOT APPLICABLE

Secondary Outcome(s)

patient comfort and surgical timingTimepoint: NOT APPLICABLE

Secondary ID(s)

NIL

Source(s) of Monetary Support

Dept of ophthalmology, KIMS,Hubli

Ethics review

Status: Approved
Approval date: 03/03/2014
Contact:

KIMS ethics committee