NCT04400097

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2020

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 20, 2020

Completed
1 day until next milestone

Study Start

First participant enrolled

May 21, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 22, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 21, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 21, 2020

Completed
Last Updated

May 22, 2020

Status Verified

May 1, 2020

Enrollment Period

6 months

First QC Date

May 20, 2020

Last Update Submit

May 20, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Patient comfort

    discomfort grading on a visual analog scale

    6 months

Study Arms (3)

hidden-knot group

EXPERIMENTAL
Procedure: suture

two-knot group

ACTIVE COMPARATOR
Procedure: suture

multi-knot group

ACTIVE COMPARATOR
Procedure: suture

Interventions

suturePROCEDURE

suture methods of autograft conjunctival transplantation

hidden-knot groupmulti-knot grouptwo-knot group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients with primary pterygium

You may not qualify if:

  • eye surgery history
  • acute ocular surface imflamation
  • patients with coagulation or diabetes mellitus

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Sutures

Intervention Hierarchy (Ancestors)

Surgical Fixation DevicesSurgical EquipmentEquipment and Supplies

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 20, 2020

First Posted

May 22, 2020

Study Start

May 21, 2020

Primary Completion

November 21, 2020

Study Completion

December 21, 2020

Last Updated

May 22, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share