PterygiumNCT01083927
Rotational Narrow Strip Versus Full Conjunctival Graft in Pterygium Excision
A study testing Rotational Narrow Strip Conjunctival Graft and Full Conjunctival Graft in people with Pterygium, run by University of Malaya at 1 site in Malaysia.
Trial summary
To compare the efficacy of rotational narrow strip conjunctival graft to full conjunctival graft in primary pterygium excision. Risk analysis of factors that may affects the recurrence rate. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pterygium
- What is being tested?
- Rotational Narrow Strip Conjunctival Graft and Full Conjunctival Graft
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteMalaysia
- Study dates
- Jul 2007to Jul 2009
- 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Significant and symptomatic primary pterygium clinically requiring excision
- Willingness to participate in research project and to attend research time
Who cannot join
- Age < 21 years
- Glaucoma in the study eye
- Other concurrent ocular surface pathology
- Infection of the ocular surface
- Poor general health
Trial locations and contacts
1 site in 1 country.
About this study
To compare the efficacy of rotational narrow strip conjunctival graft to full conjunctival graft in primary pterygium excision. Risk analysis of factors that may affects the recurrence rate.
Read the detailed description
Pterygium is a raised, wing-shaped growth of fibrovascular tissue that extends horizontally from the bulbar conjunctiva, crossing the limbus, and onto the cornea. It is a common ocular surface disease in Malaysia.
Pterygium can cause chronic ocular irritation, redness, tearing, visual impairment and poor cosmesis. Treatment of symptomatic pterygium remains surgical. Surgery should achieve low recurrence rate and acceptable cosmesis. Various surgical techniques had been described with variable success.
In this study, we compared the efficacy of Rotational Narrow Strip Conjunctival Graft with the conventional full conjunctival graft in pterygium excision. Patient will be follow up for a year after pterygium surgery. Outcome will be recurrence rate between the two groups at one year. Risk analysis of certain factors that affects the recurrence rate will be discussed.
- Conditions
- Pterygium
- Being tested
- Rotational Narrow Strip Conjunctival Graft, Full Conjunctival Graft
- Keywords
- Pterygium
- Medical subject headings
- Pterygium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rotational Narrow Strip Conjunctival GraftProcedure or surgery
Surgical technique
Full Conjunctival GraftProcedure or surgery
Surgical technique
| Study group | Role | What they receive |
|---|---|---|
| Rotational Narrow Strip Graft | Active comparator | Technique of surgery Receives: Procedure: Rotational Narrow Strip Conjunctival Graft |
| Full Graft | Active comparator | Surgical technique Receives: Procedure: Full Conjunctival Graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence Rate of Pterygium operated with Rotational Narrow Strip Conjunctival Graft and Full Conjunctival Graft Excision
Measured: 1 year
Secondary outcomes (1)
Analysis of risk factors associated with recurrence of pterygium
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2010 (estimated)
- Study startJul 2007
- Primary completionJul 2008
- Study completionJul 2009
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.
- More trials run by University of MalayaThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Malaya
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Malaysia
- Investigators
- Lo Sheau Kang, MBBS, Principal investigator, University Malaya Eye Research Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01083927
- Sponsor's protocol ID
- UMERC003
- Status last verified
- Mar 2010
- First submitted
- 8 Mar 2010
- Last updated
- 10 Mar 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rotational Narrow Strip Versus Full Conjunctival Graft in Pterygium Excision
- ClinicalTrials.gov ID
- NCT01083927
- Acronym / sponsor ID
- UMERC003
- Conditions
- Pterygium
- Keywords
- Pterygium
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- University of MalayaUniversity, hospital or other
- Collaborators
- Ministry of Health, Malaysia
- Study start
- Jul 2007
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 10 Mar 2010 (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 efficacy of rotational narrow strip conjunctival graft to full conjunctival graft in primary pterygium excision. Risk analysis of factors that may affects the recurrence rate.
Detailed description
Pterygium is a raised, wing-shaped growth of fibrovascular tissue that extends horizontally from the bulbar conjunctiva, crossing the limbus, and onto the cornea. It is a common ocular surface disease in Malaysia.
Pterygium can cause chronic ocular irritation, redness, tearing, visual impairment and poor cosmesis. Treatment of symptomatic pterygium remains surgical. Surgery should achieve low recurrence rate and acceptable cosmesis. Various surgical techniques had been described with variable success.
In this study, we compared the efficacy of Rotational Narrow Strip Conjunctival Graft with the conventional full conjunctival graft in pterygium excision. Patient will be follow up for a year after pterygium surgery. Outcome will be recurrence rate between the two groups at one year. Risk analysis of certain factors that affects the recurrence rate will be discussed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rotational Narrow Strip Graft | Active comparator | Procedure: Rotational Narrow Strip Conjunctival GraftTechnique of surgery |
| Full Graft | Active comparator | Procedure: Full Conjunctival GraftSurgical technique |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Significant and symptomatic primary pterygium clinically requiring excision
- Willingness to participate in research project and to attend research time
Key exclusion criteria (5 listed)
- Age < 21 years
- Glaucoma in the study eye
- Other concurrent ocular surface pathology
- Infection of the ocular surface
- Poor general health
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 |
|---|---|---|
| Rotational Narrow Strip Conjunctival GraftSurgical technique | Procedure or surgery | Rotational Narrow Strip Graft |
| Full Conjunctival GraftSurgical technique | Procedure or surgery | Full Graft |
Primary outcome
Recurrence Rate of Pterygium operated with Rotational Narrow Strip Conjunctival Graft and Full Conjunctival Graft Excision
Time frame: 1 year
1 secondary outcome
Analysis of risk factors associated with recurrence of pterygium
Time frame: 1 year
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 10 Mar 2010.
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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.
Lo Sheau Kang, MBBS principal investigator
University Malaya Eye Research Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rotational Narrow Strip Conjunctival Graft and Full Conjunctival Graft in people with Pterygium, run by University of Malaya at 1 site in Malaysia.
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 2 inclusion and 5 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 10 Mar 2010. 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 Malaysia. 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?
Recurrence Rate of Pterygium operated with Rotational Narrow Strip Conjunctival Graft and Full Conjunctival Graft Excision (time frame: 1 year). 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 10 Mar 2010.