Recurrence Rate of Mini-SLET vs. Limbal-Conjunctival Autograft in Primary Pterygium Excision
Primary Purpose
Pterygium of Conjunctiva and Cornea
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Pterygium Excision
Sponsored by
About this trial
This is an interventional treatment trial for Pterygium of Conjunctiva and Cornea focused on measuring Crosslinking
Eligibility Criteria
Inclusion Criteria:
- Patients with primary nasal pterygium > 2mm
Exclusion Criteria:
- Pregnant
- Previous ocular surgery
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Mini-SLET
Limbal-Conjunctival Autograft
Arm Description
Simple Limbal Epithelial Transplantation
Patients treated with limbal-conjunctival autograft
Outcomes
Primary Outcome Measures
Recurrence rate
Regrowth of pterygium
Secondary Outcome Measures
Full Information
NCT ID
NCT03363282
First Posted
November 30, 2017
Last Updated
March 7, 2018
Sponsor
Instituto de Oftalmología Fundación Conde de Valenciana
1. Study Identification
Unique Protocol Identification Number
NCT03363282
Brief Title
Recurrence Rate of Mini-SLET vs. Limbal-Conjunctival Autograft in Primary Pterygium Excision
Official Title
Recurrence Rate of Mini-SLET (Simple Limbal Epithelial Transplantation) vs. Limbal-Conjunctival Autograft in Primary Pterygium Excision
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
September 17, 2015 (Actual)
Primary Completion Date
November 17, 2016 (Actual)
Study Completion Date
November 28, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Instituto de Oftalmología Fundación Conde de Valenciana
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To study the efficacy and safety of amniotic membrane transplantation as an adjunctive therapy after surgical excision of primary pterygium and compare the clinical outcomes with conjunctival autograft
Detailed Description
Prospective Randomized Blind Clinical Trial
Sixty-four eyes of 64 patients with primary nasal pterygium have been operated by two surgeons (E. G-H, A. N-C). All patients are randomized to undergo Mini-SLET or limbal-conjunctival autograft transplantation as an adjuvant therapy after pterygium excision.
Four eyes were treated with Mini-SLET(group 1), and 26 eyes have been operated with conjunctival autograft (group 2). Patients will be followed up at 1 day, 1 week, 1, 3, 6, 9 and 12 months postoperation. The main outcome measurement was a recurrence rate after surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pterygium of Conjunctiva and Cornea
Keywords
Crosslinking
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
57 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mini-SLET
Arm Type
Experimental
Arm Description
Simple Limbal Epithelial Transplantation
Arm Title
Limbal-Conjunctival Autograft
Arm Type
Experimental
Arm Description
Patients treated with limbal-conjunctival autograft
Intervention Type
Procedure
Intervention Name(s)
Pterygium Excision
Other Intervention Name(s)
Limbal-Conjunctival Autograft, Mini-SLET
Intervention Description
Pterygium excision is the first step for repair
Primary Outcome Measure Information:
Title
Recurrence rate
Description
Regrowth of pterygium
Time Frame
one day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients with primary nasal pterygium > 2mm
Exclusion Criteria:
Pregnant
Previous ocular surgery
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Patient data will be analyzed by a single researcher
Citations:
PubMed Identifier
2695347
Citation
Tseng SC. Concept and application of limbal stem cells. Eye (Lond). 1989;3 ( Pt 2):141-57. doi: 10.1038/eye.1989.22.
Results Reference
result
PubMed Identifier
15220729
Citation
Tananuvat N, Martin T. The results of amniotic membrane transplantation for primary pterygium compared with conjunctival autograft. Cornea. 2004 Jul;23(5):458-63. doi: 10.1097/01.ico.0000116522.57227.97.
Results Reference
result
PubMed Identifier
17457187
Citation
Kucukerdonmez C, Akova YA, Altinors DD. Comparison of conjunctival autograft with amniotic membrane transplantation for pterygium surgery: surgical and cosmetic outcome. Cornea. 2007 May;26(4):407-13. doi: 10.1097/ICO.0b013e318033b3d4.
Results Reference
result
Learn more about this trial
Recurrence Rate of Mini-SLET vs. Limbal-Conjunctival Autograft in Primary Pterygium Excision
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