Pterygium of Conjunctiva and CorneaNCT03507283
Vertical Split Conjunctival Autograft in Double-head Pterygia
An observational study of Pterygium of Conjunctiva and Cornea, run by Benha University.
Trial summary
15 eyes of 15 patients with primary double-headed pterygia that underwent vertical split conjunctival autograft pterygium surgery were retrospectively reviewed. All patients had primary double-headed pterygia. Recurrence was defined as fibrovascular proliferation over the limbus onto the cornea. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pterygium of Conjunctiva and Cornea
- What is being tested?
- Double head pterygia excision and repair
- Type of treatment
- Surgery or procedure
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- Apr 2011to Aug 2016
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study included 15 eyes of 15 patients. The mean age of all patients was 36.92 ± 10.8 years. There were 9 males (60%) and 6 females (40%).
Who may be able to join
- Primary double-headed pterygia
Who cannot join
- NONE
About this study
Official title: Outcomes of Vertical Split Conjunctival Autograft Using Fibrin Glue in Treatment of Primary Double-head Pterygia
15 eyes of 15 patients with primary double-headed pterygia that underwent vertical split conjunctival autograft pterygium surgery were retrospectively reviewed. All patients had primary double-headed pterygia. Recurrence was defined as fibrovascular proliferation over the limbus onto the cornea.
Vertical split conjunctival autograft using fibrin glue is an effective technique with good cosmetic results and low to no recurrence for primary double head pterygia treatment.
Read the detailed description
The pterygium body was dissected from the sclera. Complete excision of the pterygium, subconjunctival Tenon's tissue and surrounding fibrovascular tissues followed.The conjunctival edge was trimmed. The corneal surface was gently scraped with a scalpel. The Same procedure was done on temporal pterygia. A free conjunctival autograft was obtained. The graft was divided vertically into two parts. The nasal part of the graft was cut from limbal attachment including limbal tissue; temporal part was left attached. The nasal part of the graft was moved to the nasal conjunctival defect and attached to the sclera with fibrin sealant (Tisseel; Baxter, Vienna, Austria). The Same procedure was done with the temporal part of the graft. The orientation of graft was ensured before securing it.
- Conditions
- Pterygium of Conjunctiva and Cornea
- Being tested
- Double head pterygia excision and repair
- Keywords
- Pterygium, double-headed, vertical
- Medical subject headings
- Pterygium Of Conjunctiva And Cornea, Pterygium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Double head pterygia excision and repairProcedure or surgery
Complete excision of the pterygia was done. A free conjunctival autograft was obtained. The graft was divided vertically into two parts then secured into conjunctival defects.
What is being measured
The primary outcome is the main question the study is designed to answer.
The recurrence rate
fibrovascular tissue invading the cornea and expressed as a percentage
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 posted25 Apr 2018
- Study startApr 2011
- Primary completionApr 2016
- Study completionAug 2016
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 Pterygium of Conjunctiva and CorneaStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tarek Roshdy mohamed Mahgoub ELhamaky, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03507283
- Sponsor's protocol ID
- benha19991
- Status last verified
- Apr 2018
- First submitted
- 15 Apr 2018
- Last updated
- 26 Apr 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Elhamaky TR, Elbarky AM. Outcomes of Vertical Split Conjunctival Autograft Using Fibrin Glue in Treatment of Primary Double-Headed Pterygia. J Ophthalmol. 2018 Dec 20;2018:9341846. doi: 10.1155/2018/9341846. eCollection 2018.
PubMed 30671262
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Vertical Split Conjunctival Autograft Using Fibrin Glue in Treatment of Primary Double-head Pterygia
- ClinicalTrials.gov ID
- NCT03507283
- Acronym / sponsor ID
- benha19991
- Conditions
- Pterygium of Conjunctiva and Cornea
- Keywords
- Pterygium, double-headed, vertical
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- Apr 2011 (actual)
- Primary completion
- Apr 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 25 Apr 2018 (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.
15 eyes of 15 patients with primary double-headed pterygia that underwent vertical split conjunctival autograft pterygium surgery were retrospectively reviewed. All patients had primary double-headed pterygia. Recurrence was defined as fibrovascular proliferation over the limbus onto the cornea.
Vertical split conjunctival autograft using fibrin glue is an effective technique with good cosmetic results and low to no recurrence for primary double head pterygia treatment.
Detailed description
The pterygium body was dissected from the sclera. Complete excision of the pterygium, subconjunctival Tenon's tissue and surrounding fibrovascular tissues followed.The conjunctival edge was trimmed. The corneal surface was gently scraped with a scalpel. The Same procedure was done on temporal pterygia. A free conjunctival autograft was obtained. The graft was divided vertically into two parts. The nasal part of the graft was cut from limbal attachment including limbal tissue; temporal part was left attached. The nasal part of the graft was moved to the nasal conjunctival defect and attached to the sclera with fibrin sealant (Tisseel; Baxter, Vienna, Austria). The Same procedure was done with the temporal part of the graft. The orientation of graft was ensured before securing it.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study included 15 eyes of 15 patients. The mean age of all patients was 36.92 ± 10.8 years. There were 9 males (60%) and 6 females (40%).
Key inclusion criteria (1 listed)
- Primary double-headed pterygia
Key exclusion criteria (1 listed)
- NONE
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 |
|---|---|---|
| Double head pterygia excision and repairComplete excision of the pterygia was done. A free conjunctival autograft was obtained. The graft was divided vertically into two parts then secured into conjunctival defects. | Procedure or surgery | – |
Primary outcome
The recurrence rate
Time frame: 1 year
fibrovascular tissue invading the cornea and expressed as a percentage
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 26 Apr 2018.
- Derived from this study: PubMed 30671262Elhamaky TR, Elbarky AM. Outcomes of Vertical Split Conjunctival Autograft Using Fibrin Glue in Treatment of Primary Double-Headed Pterygia. J Ophthalmol. 2018 Dec 20;2018:9341846. doi: 10.1155/2018/9341846. eCollection 2018.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Pterygium of Conjunctiva and Cornea, run by Benha 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 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 26 Apr 2018. 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?
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 recurrence rate (time frame: 1 year). 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 NCT03507283, 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 26 Apr 2018.