PterygiumNCT00713180
Determinants of Pterygium Occurrence and Recurrence in a Rural African Population
A study testing Pterygium excision followed by grafting in people with Pterygium, run by Anguria, Peter, M.D. at 1 site in South Africa.
Trial summary
The aim of the study is to find out why pterygium occurs and recurs in a rural African population. Participants will be interviewed on personal and lifestyle information, family history of pterygium, environmental exposure and history of previous eye inflammation. They will undergo eye examination and photography. Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Pterygium
- What is being tested?
- Pterygium excision followed by grafting
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 355 participants
- Where
- 1 siteSouth Africa
- Study dates
- Aug 2008to Feb 2012
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Pterygium at least 1.5mm in extent
- Both male and female
- Age range 21-65 years
- Consenting to participate in study
- Unilateral and bilateral pterygium
- All grades of pterygium
Who cannot join
- Previous cataract, corneoscleral and glaucoma surgery or corneoscleral trauma and corneolimbal scars
- Pseudopterygium or signs of malignancy on pterygium
- Recurrent pterygium
- Sufferers of collagen vascular disease, scleritis or diabetes -
Trial locations and contacts
1 site in 1 country.
About this study
The aim of the study is to find out why pterygium occurs and recurs in a rural African population. Participants will be interviewed on personal and lifestyle information, family history of pterygium, environmental exposure and history of previous eye inflammation. They will undergo eye examination and photography. Those with pterygium will be operated on to remove pterygium and followed up to detect any recurrence and complications of surgery. The excised pterygium will be examined pathologically and genetically; participant's blood will also be examined genetically. Data will be analyzed for statistically significant differences in findings between pterygium and pterygium free participants.
The study hypothesis is that multiple factors are responsible for the occurrence and recurrence of pterygium in a rural african population.
- Conditions
- Pterygium
- Being tested
- Pterygium excision followed by grafting
- Medical subject headings
- Pterygium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pterygium excision followed by graftingProcedure or surgery
Pterygium will be excised followed by either free conjunctival or limbal conjunctival graft obtained from the upper part of the globe. The graft will be kept in place by sutures
| Study group | Role | What they receive |
|---|---|---|
| 1 | No intervention | Pterygium free participants |
| 2 | Experimental | Pterygium participants Receives: Procedure: Pterygium excision followed by grafting |
What is being measured
The primary outcome is the main question the study is designed to answer.
None recurrence of pterygium
Measured: 6 months of follow up after operation
Secondary outcomes (5)
corneal scarring
Measured: 6 months of follow up
tenon's granuloma
Measured: 6 months of follow up
graft retraction
Measured: one month of follow up
Graft haematoma
Measured: one week of follow up
Graft hyperaemia
Measured: 3 months of follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2008 (estimated)
- Study startAug 2008
- Primary completionFeb 2012
- Study completionFeb 2012
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 355 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anguria, Peter, M.D.
- Investigators
- Peter Anguria, MMed, Principal investigator, Mankweng Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00713180
- Sponsor's protocol ID
- Research laboratory
- Status last verified
- Aug 2008
- First submitted
- 9 Jul 2008
- Last updated
- 25 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determinants of Pterygium Occurrence and Recurrence in a Rural African Population
- ClinicalTrials.gov ID
- NCT00713180
- Acronym / sponsor ID
- Research laboratory
- Conditions
- Pterygium
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 355 participants (estimated)
- Lead sponsor
- Anguria, Peter, M.D.
- Study start
- Aug 2008
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 11 Jul 2008 (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.
The aim of the study is to find out why pterygium occurs and recurs in a rural African population. Participants will be interviewed on personal and lifestyle information, family history of pterygium, environmental exposure and history of previous eye inflammation. They will undergo eye examination and photography. Those with pterygium will be operated on to remove pterygium and followed up to detect any recurrence and complications of surgery. The excised pterygium will be examined pathologically and genetically; participant's blood will also be examined genetically. Data will be analyzed for statistically significant differences in findings between pterygium and pterygium free participants.
The study hypothesis is that multiple factors are responsible for the occurrence and recurrence of pterygium in a rural african population.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | No intervention | –Pterygium free participants |
| 2 | Experimental | Procedure: Pterygium excision followed by graftingPterygium participants |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Pterygium at least 1.5mm in extent
- Both male and female
- Age range 21-65 years
- Consenting to participate in study
- Unilateral and bilateral pterygium
Key exclusion criteria (4 listed)
- Previous cataract, corneoscleral and glaucoma surgery or corneoscleral trauma and corneolimbal scars
- Pseudopterygium or signs of malignancy on pterygium
- Recurrent pterygium
- Sufferers of collagen vascular disease, scleritis or diabetes -
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 |
|---|---|---|
| Pterygium excision followed by graftingPterygium will be excised followed by either free conjunctival or limbal conjunctival graft obtained from the upper part of the globe. The graft will be kept in place by sutures | Procedure or surgery | 2 |
Primary outcome
None recurrence of pterygium
Time frame: 6 months of follow up after operation
5 secondary outcomes
corneal scarring
Time frame: 6 months of follow up
tenon's granuloma
Time frame: 6 months of follow up
graft retraction
Time frame: one month of follow up
Graft haematoma
Time frame: one week of follow up
Graft hyperaemia
Time frame: 3 months of follow up
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 25 Jun 2015.
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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.
Peter Anguria, MMed principal investigator
Mankweng 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 Pterygium excision followed by grafting in people with Pterygium, run by Anguria, Peter, M.D. at 1 site in South Africa.
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 6 inclusion and 4 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 25 Jun 2015. 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 South Africa. 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?
None recurrence of pterygium (time frame: 6 months of follow up after operation). 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 25 Jun 2015.