PterygiumNCT00391573
Polyglactin Sutures Versus Nylon Sutures for Suturing of Conjunctival Autograft in Pterygium Surgery: a Randomised Controlled Trial
A study testing Polyglactin sutures for suturing of conjunctival autograft in pterygium surgery and Nylon sutures for suturing of conjunctival autograft in pterygium surgery in people with Pterygium, run by Hospital Authority, Hong Kong at 1 site in China.
Trial summary
To compare the use of polyglactin sutures versus nylon sutures for conjunctival autograft suturing in pterygium surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pterygium
- What is being tested?
- Polyglactin sutures for suturing of conjunctival autograft in pterygium surgery and Nylon sutures for suturing of conjunctival autograft in pterygium surgery
- Type of treatment
- Surgery or procedure
- How many people
- 32 participants
- Where
- 1 siteChina
- Study dates
- Mar 2005to Jun 2005
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Inclusion criteria included patients with primary nasal pterygium, aged 18 years or older, and able to cooperate surgery under local anaesthesia.
Who cannot join
- Patients with recurrent pterygium, scarred superior conjunctiva, previous surgery involving the superior bulbar conjunctiva, history of glaucoma, and cicatricial ocular surface disease were excluded
Trial locations and contacts
1 site in 1 country.
About this study
To compare the use of polyglactin sutures versus nylon sutures for conjunctival autograft suturing in pterygium surgery.
- Conditions
- Pterygium
- Being tested
- Polyglactin sutures for suturing of conjunctival autograft in pterygium surgery, Nylon sutures for suturing of conjunctival autograft in pterygium surgery
- Medical subject headings
- Pterygium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polyglactin sutures for suturing of conjunctival autograft in pterygium surgeryProcedure or surgery
Nylon sutures for suturing of conjunctival autograft in pterygium surgeryProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference in VAS score between the two groups
Secondary outcomes (3)
Graft hyperemia, oedema and tarsal conjunctival papillary hypertrophy
Surgical complications
Pterygium recurrence
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2006 (estimated)
- Study startMar 2005
- Study completionJun 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PterygiumStudies 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
- Single group
- Masking
- Single blind
- Enrolment
- 32 participants
Sponsor and investigators
- Lead sponsor
- Hospital Authority, Hong Kong
- Sponsor type
- Other government
- Investigators
- Victoria Wong, Dr, Principal investigator, Hong Kong Eye Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00391573
- Sponsor's protocol ID
- KC/KE-05-0008
- Other IDs
- HARECCTR0500063
- Status last verified
- Jun 2011
- First submitted
- 23 Oct 2006
- Last updated
- 16 Jun 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Polyglactin Sutures Versus Nylon Sutures for Suturing of Conjunctival Autograft in Pterygium Surgery: a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT00391573
- Acronym / sponsor ID
- KC/KE-05-0008
- Conditions
- Pterygium
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants
- Lead sponsor
- Hospital Authority, Hong KongOther government
- Study start
- Mar 2005
- Study completion
- Jun 2005
- First posted
- 24 Oct 2006 (estimated)
- 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 compare the use of polyglactin sutures versus nylon sutures for conjunctival autograft suturing in pterygium surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Inclusion criteria included patients with primary nasal pterygium, aged 18 years or older, and able to cooperate surgery under local anaesthesia.
Key exclusion criteria (1 listed)
- Patients with recurrent pterygium, scarred superior conjunctiva, previous surgery involving the superior bulbar conjunctiva, history of glaucoma, and cicatricial ocular surface disease were excluded
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 |
|---|---|---|
| Polyglactin sutures for suturing of conjunctival autograft in pterygium surgery | Procedure or surgery | – |
| Nylon sutures for suturing of conjunctival autograft in pterygium surgery | Procedure or surgery | – |
Primary outcome
The difference in VAS score between the two groups
3 secondary outcomes
Graft hyperemia, oedema and tarsal conjunctival papillary hypertrophy
Surgical complications
Pterygium recurrence
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2011.
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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.
Victoria Wong, Dr principal investigator
Hong Kong Eye Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Polyglactin sutures for suturing of conjunctival autograft in pterygium surgery and Nylon sutures for suturing of conjunctival autograft in pterygium surgery in people with Pterygium, run by Hospital Authority, Hong Kong at 1 site in China.
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 1 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: finished, as of the sponsor's last update on 16 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The difference in VAS score between the two groups. 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 16 Jun 2011.