Recurrent PterygiumNCT02059837
Clinical Analysis of Recurrence Patterns Following Conjunctival Autografts for Pterygium Surgery
An observational study of Recurrent Pterygium, run by Kyungpook National University Hospital at 1 site in South Korea.
Trial summary
This study is conducted to evaluate its morphologic reproliferating patterns in patients with pterygium treated with the excision and conjunctival autograft. Read more about this study
- Who is it for?
- Ages 21 to 85 years
- Conditions the study is for
- Recurrent Pterygium
- What is being tested?
- recurrent pterygium excision and following grafting
- Type of treatment
- Surgery or procedure
- How many people
- 116 participants
- Where
- 1 siteSouth Korea
- Study dates
- Feb 2009to Oct 2011
- Phase
- Observational
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: A total of 116 patients were included. They had pterygium excision and conjunctival autograft surgery and followed by anterior photographs.
Who may be able to join
- Recurrent pterygium
- Unilateral or bilateral pterygium
- Both male and female
- Consenting to participate in study
Who cannot join
- Fibrovascular proliferation secondary to injury
- Severe dry eye syndrome
- Pseudopterygium
- Signs of malignancy on pterygium
- Corneoscleral trauma or corneo-limbal scars
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Retrospective Study of Recurrence Patterns Following Conjunctival Autografts for Pterygium Surgery
This study is conducted to evaluate its morphologic reproliferating patterns in patients with pterygium treated with the excision and conjunctival autograft.
Read the detailed description
The medical records of 116 eyes of 116 patients with pterygium who had pterygium excision and conjunctival autograft between February 2009 and May 2011 were reviewed. Using consecutively recorded photographs, we evaluated preoperative morphologic characteristics and its growth patterns.
- Conditions
- Recurrent Pterygium
- Being tested
- recurrent pterygium excision and following grafting
- Medical subject headings
- Pterygium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
recurrent pterygium excision and following graftingProcedure or surgery
The excision of recurrent pterygial tissue and autograft of conjunctiva was done.
| Study group | Role | What they receive |
|---|---|---|
| Pterygium,recurrent | Consecutively recorded photographs of recurrent pterygium excision and following grafting were analyzed. Receives: Procedure: recurrent pterygium excision and following grafting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pterygium recurrence pattern
Morphologic recurrence pattern of pterygium using consecutively recorded photographs.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2014 (estimated)
- Study startFeb 2009
- Primary completionMay 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Recurrent 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyungpook National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hong Kyun Kim, M.D, Kyungpook National University Hospital
- Investigators
- Hong Kyun Kim, M.D., Principal investigator, Kyungpook National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02059837
- Sponsor's protocol ID
- KNUH 2014-1
- Status last verified
- Feb 2014
- First submitted
- 10 Feb 2014
- Last updated
- 11 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kwon SH, Kim HK. Analysis of recurrence patterns following pterygium surgery with conjunctival autografts. Medicine (Baltimore). 2015 Jan;94(4):e518. doi: 10.1097/MD.0000000000000518.
PubMed 25634207
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Study of Recurrence Patterns Following Conjunctival Autografts for Pterygium Surgery
- ClinicalTrials.gov ID
- NCT02059837
- Acronym / sponsor ID
- KNUH 2014-1
- Conditions
- Recurrent Pterygium
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Kyungpook National University HospitalUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- May 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 11 Feb 2014 (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.
This study is conducted to evaluate its morphologic reproliferating patterns in patients with pterygium treated with the excision and conjunctival autograft.
Detailed description
The medical records of 116 eyes of 116 patients with pterygium who had pterygium excision and conjunctival autograft between February 2009 and May 2011 were reviewed. Using consecutively recorded photographs, we evaluated preoperative morphologic characteristics and its growth patterns.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pterygium,recurrent | – | Procedure: recurrent pterygium excision and following graftingConsecutively recorded photographs of recurrent pterygium excision and following grafting were analyzed. |
Who may qualify
- Ages
- 21 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A total of 116 patients were included. They had pterygium excision and conjunctival autograft surgery and followed by anterior photographs.
Key inclusion criteria (4 listed)
- Recurrent pterygium
- Unilateral or bilateral pterygium
- Both male and female
- Consenting to participate in study
Key exclusion criteria (5 listed)
- Fibrovascular proliferation secondary to injury
- Severe dry eye syndrome
- Pseudopterygium
- Signs of malignancy on pterygium
- Corneoscleral trauma or corneo-limbal scars
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 |
|---|---|---|
| recurrent pterygium excision and following graftingThe excision of recurrent pterygial tissue and autograft of conjunctiva was done. | Procedure or surgery | Pterygium,recurrent |
Primary outcome
Pterygium recurrence pattern
Time frame: 12 months
Morphologic recurrence pattern of pterygium using consecutively recorded photographs.
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 11 Feb 2014.
- Derived from this study: PubMed 25634207Kwon SH, Kim HK. Analysis of recurrence patterns following pterygium surgery with conjunctival autografts. Medicine (Baltimore). 2015 Jan;94(4):e518. doi: 10.1097/MD.0000000000000518.
Related trials for Recurrent Pterygium
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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.
Hong Kyun Kim, M.D. principal investigator
Kyungpook National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Recurrent Pterygium, run by Kyungpook National University Hospital at 1 site in South Korea.
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 4 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 11 Feb 2014. 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 Korea. 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?
Pterygium recurrence pattern (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02059837, which also lists 1 linked publication.
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 11 Feb 2014.