the Efficacy and Effect on Patient Comfort of a Hidden-knot Continuous Suture for Pterygium Excision With Conjunctival AutograftNCT04400097
The Influence of Suture Method in Conjunctival Autograft Transplantation on Postoperative Ocular Discomfort for Primary Pterygium
A study testing suture in people with the Efficacy and Effect on Patient Comfort of a Hidden-knot Continuous Suture for Pterygium Excision With Conjunctival Autograft, run by Aier School of Ophthalmology, Central South University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- the Efficacy and Effect on Patient Comfort of a Hidden-knot Continuous Suture for Pterygium Excision With Conjunctival Autograft
- What is being tested?
- suture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 21 May 2020to 21 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with primary pterygium
Who cannot join
- eye surgery history
- acute ocular surface imflamation
- patients with coagulation or diabetes mellitus
Trial locations and contacts
No sites are listed yet.
About this study
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.
- Being tested
- suture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sutureProcedure or surgery
suture methods of autograft conjunctival transplantation
| Study group | Role | What they receive |
|---|---|---|
| hidden-knot group | Experimental | Not described Receives: Procedure: suture |
| two-knot group | Active comparator | Not described Receives: Procedure: suture |
| multi-knot group | Active comparator | Not described Receives: Procedure: suture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient comfort
discomfort grading on a visual analog scale
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2020
- Study start21 May 2020 (estimated)
- Primary completion21 Nov 2020 (estimated)
- Study completion21 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for the Efficacy and Effect on Patient Comfort of a Hidden-knot Continuous Suture for Pterygium Excision With Conjunctival AutograftStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aier School of Ophthalmology, Central South University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04400097
- Sponsor's protocol ID
- SHAIER2020IRB03
- Status last verified
- May 2020
- First submitted
- 20 May 2020
- Last updated
- 22 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Suture Method in Conjunctival Autograft Transplantation on Postoperative Ocular Discomfort for Primary Pterygium
- ClinicalTrials.gov ID
- NCT04400097
- Acronym / sponsor ID
- SHAIER2020IRB03
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Aier School of Ophthalmology, Central South UniversityUniversity, hospital or other
- Study start
- 21 May 2020 (estimated)
- Primary completion
- 21 Nov 2020 (estimated)
- Study completion
- 21 Dec 2020 (estimated)
- First posted
- 22 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| hidden-knot group | Experimental | Procedure: suture |
| two-knot group | Active comparator | Procedure: suture |
| multi-knot group | Active comparator | Procedure: suture |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients with primary pterygium
Key exclusion criteria (3 listed)
- eye surgery history
- acute ocular surface imflamation
- patients with coagulation or diabetes mellitus
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| suturesuture methods of autograft conjunctival transplantation | Procedure or surgery | hidden-knot group, multi-knot group, two-knot group |
Primary outcome
Patient comfort
Time frame: 6 months
discomfort grading on a visual analog scale
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2020.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing suture in people with the Efficacy and Effect on Patient Comfort of a Hidden-knot Continuous Suture for Pterygium Excision With Conjunctival Autograft, run by Aier School of Ophthalmology, Central South University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 May 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yan Chen, doctor (+86-021-62956699, chinacy@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient comfort (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2020.