CClinicalTrials.gg
Status unknownNCT04400097Updated May 22, 2020

The Influence of Suture Method in Conjunctival Autograft Transplantation on Postoperative Ocular Discomfort for Primary Pterygium

An interventional study of suture in the Efficacy and Effect on Patient Comfort of a Hidden-knot Continuous Suture for Pterygium Excision With Conjunctival Autograft, sponsored by Aier School of Ophthalmology, Central South University. Status unknown. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2020-05-22.

Sponsored by Aier School of Ophthalmology, Central South University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified May 2020), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • the Efficacy and Effect on Patient Comfort of a Hidden-knot Continuous Suture for Pterygium Excision With Conjunctival Autograft

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03

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • patients with primary pterygium

Exclusion criteria

Exclusion Criteria:

  • eye surgery history
  • acute ocular surface imflamation
  • patients with coagulation or diabetes mellitus
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    hidden-knot group

    Procedure: suture

  • Active comparator
    two-knot group

    Procedure: suture

  • Active comparator
    multi-knot group

    Procedure: suture

Interventions

  • Proceduresuture

    suture methods of autograft conjunctival transplantation

05

What researchers measure

Primary outcomes

  1. Patient comfort

    discomfort grading on a visual analog scale

    Time frame: 6 months

06

Study locations

No study locations are listed for this record.

07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT04400097
Lead sponsor
Aier School of Ophthalmology, Central South University
Responsible party
Sponsor
First posted
May 22, 2020
Start date
May 21, 2020 (estimated)
Primary completion
Nov 21, 2020 (estimated)
Completion
Dec 21, 2020 (estimated)
Last update
May 22, 2020

Study contacts

Yan Chen, doctor
Contact
chinacy@hotmail.com
+86-021-62956699

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2020. You cannot join it, but the record below documents what was studied.

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