Back to resultsThe Influence of Suture Method in Conjunctival Autograft Transplantation on Postoperative Ocular Discomfort for Primary Pterygium
Primary Purpose
the Efficacy and Effect on Patient Comfort of a Hidden-knot Continuous Suture for Pterygium Excision With Conjunctival Autograft
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
suture
Sponsored by
About this trial
This is an interventional treatment trial for the Efficacy and Effect on Patient Comfort of a Hidden-knot Continuous Suture for Pterygium Excision With Conjunctival Autograft
Eligibility Criteria
Inclusion Criteria:
- patients with primary pterygium
Exclusion Criteria:
- eye surgery history
- acute ocular surface imflamation
- patients with coagulation or diabetes mellitus
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
hidden-knot group
two-knot group
multi-knot group
Arm Description
Outcomes
Primary Outcome Measures
Patient comfort
discomfort grading on a visual analog scale
Secondary Outcome Measures
Full Information
NCT ID
NCT04400097
First Posted
May 20, 2020
Last Updated
May 20, 2020
Sponsor
Aier School of Ophthalmology, Central South University
1. Study Identification
Unique Protocol Identification Number
NCT04400097
Brief Title
The Influence of Suture Method in Conjunctival Autograft Transplantation on Postoperative Ocular Discomfort for Primary Pterygium
Official Title
The Influence of Suture Method in Conjunctival Autograft Transplantation on Postoperative Ocular Discomfort for Primary Pterygium
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Unknown status
Study Start Date
May 21, 2020 (Anticipated)
Primary Completion Date
November 21, 2020 (Anticipated)
Study Completion Date
December 21, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aier School of Ophthalmology, Central South University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
To evaluate the efficacy and effect on patient comfort of a hidden-knot continuous suture for pterygium excision with conjunctival autograft，compared with two-knot continuous sutures and multi-knot interrupted sutures.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
the Efficacy and Effect on Patient Comfort of a Hidden-knot Continuous Suture for Pterygium Excision With Conjunctival Autograft
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
hidden-knot group
Arm Type
Experimental
Arm Title
two-knot group
Arm Type
Active Comparator
Arm Title
multi-knot group
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
suture
Intervention Description
suture methods of autograft conjunctival transplantation
Primary Outcome Measure Information:
Title
Patient comfort
Description
discomfort grading on a visual analog scale
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients with primary pterygium
Exclusion Criteria:
eye surgery history
acute ocular surface imflamation
patients with coagulation or diabetes mellitus
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yan Chen, doctor
Phone
+86-021-62956699
Email
chinacy@hotmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Influence of Suture Method in Conjunctival Autograft Transplantation on Postoperative Ocular Discomfort for Primary Pterygium
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