PterygiumNCT03377348
Subconjunctival Injection of Triamcinolone Acetonide and Limited Peritomy During Pterygium Excision
A study testing intraoperative subconjunctival injection of triamcinolone acetonide and limited peritomy during bare scleral pterygium excision in people with Pterygium, run by Assiut University at 1 site in Egypt.
Trial summary
Pterygium is characterized by encroachment of a fleshy fibrovascular tissue from the bulbar conjunctiva on to the cornea. Although previously thought to be a solely degenerative disease, a new evidence has demonstrated the role of cell proliferation and inflammation in the pathogenesis of pterygium , and also by the… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pterygium
- What is being tested?
- intraoperative subconjunctival injection of triamcinolone acetonide and limited peritomy during bare scleral pterygium excision
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2017to 1 Dec 2019
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- primary pterygium.
Who cannot join
- preexisting glaucoma .
- patient with family history of glaucoma
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Use of Intraoperative Subconjunctival Injection of Triamcinolone Acetonide and Limited Peritomy During Bare Scleral Pterygium Excision
Pterygium is characterized by encroachment of a fleshy fibrovascular tissue from the bulbar conjunctiva on to the cornea. Although previously thought to be a solely degenerative disease, a new evidence has demonstrated the role of cell proliferation and inflammation in the pathogenesis of pterygium , and also by the clinical data that steroids are beneficial in halting progression of impending recurrent pterygium . Many techniques have been developed for pterygium surgery over time. The simple method of removing the head and body of pterygium and leaving the sclera uncovered, the so-called bare-sclera technique, has been associated with high recurrence rates of 32-88% . To reduce the recurrence rate after pterygium surgery with a bare-sclera technique, various adjunctive modalities have been used such as chemical agents including mitomycin C , 5-fluorouracil . Furthermore, when removal of pterygium is accompanied with a graft, such as conjunctival autograft or amniotic membrane transplantation , lower recurrence rates have been achieved . However, it remains unclear why the bare sclera technique has poorer outcome with higher recurrence rate than other procedures.
Read the detailed description
One of the factors that may have a role in the outcome of pterygium surgery is postoperative conjunctival inflammation , treatment of which has been demonstrated to improve the final outcome . It has been shown that persistent conjunctival inflammation around the surgical site after pterygium surgery is present in 31-84% of cases with amniotic membrane transplantation, and in 15% of eyes with conjunctival autograft . However, the rate of conjunctival inflammation after pterygium surgery with a bare-sclera technique has not been reported in literature . Also, it has been suggested that higher recurrence rate after pterygium with amniotic membrane transplantation compared with conjunctival autograft may be due to higher rate of postoperative conjunctival inflammation . Therefore, it may be speculated that higher recurrence rate after pterygium surgery with a bare-sclera technique is partly due to higher rate of postoperative conjunctival inflammation .
- Conditions
- Pterygium
- Being tested
- intraoperative subconjunctival injection of triamcinolone acetonide and limited peritomy during bare scleral pterygium excision
- Medical subject headings
- Pterygium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intraoperative subconjunctival injection of triamcinolone acetonide and limited peritomy during bare scleral pterygium excisionProcedure or surgery
intraoperative subconjunctival injection of triamcinolone acetonide and limited peritomy during bare scleral pterygium excision
| Study group | Role | What they receive |
|---|---|---|
| subconjunctival injection of triamcinolone acetonide | Other | intraoperative subconjunctival injection of triamcinolone acetonide and limited peritomy during bare scleral pterygium excision Receives: Procedure: intraoperative subconjunctival injection of triamcinolone acetonide and limited peritomy during bare scleral pterygium excision |
What is being measured
The primary outcome is the main question the study is designed to answer.
the rate of recurrence by grading system of Prabhasawat
it is a grade to follow up the recurrence of pterygium which classifies pterygium excision outcome from grades 1 to 4:
- Grade 1 : indicates a normal appearance of the operated site .
- Grade 2 : indicates the presence of fine episcleral vessels in the excised area, extending to the limbus but without any fibrous tissue .
- Grade 3 : indicates fibrovascular tissue in the excised area, reaching to the limbus but not invading the cornea and significant conjunctival recurrence .
- Grade 4: indicates a true corneal recurrence with fibrovascular tissue invading the cornea.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2017
- Study start1 Dec 2017
- Primary completion1 Aug 2019
- Study completion1 Dec 2019
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 Assiut UniversityThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alaa Mohamed Abdelhafez, Assiut University
- Investigators
- Alaa Abdelhafez, Master Degree, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03377348
- Sponsor's protocol ID
- TIP
- Status last verified
- Feb 2021
- First submitted
- 14 Dec 2017
- Last updated
- 23 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Use of Intraoperative Subconjunctival Injection of Triamcinolone Acetonide and Limited Peritomy During Bare Scleral Pterygium Excision
- ClinicalTrials.gov ID
- NCT03377348
- Acronym / sponsor ID
- TIP
- Conditions
- Pterygium
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 1 Aug 2019 (actual)
- Study completion
- 1 Dec 2019 (actual)
- First posted
- 19 Dec 2017 (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.
Pterygium is characterized by encroachment of a fleshy fibrovascular tissue from the bulbar conjunctiva on to the cornea. Although previously thought to be a solely degenerative disease, a new evidence has demonstrated the role of cell proliferation and inflammation in the pathogenesis of pterygium , and also by the clinical data that steroids are beneficial in halting progression of impending recurrent pterygium . Many techniques have been developed for pterygium surgery over time. The simple method of removing the head and body of pterygium and leaving the sclera uncovered, the so-called bare-sclera technique, has been associated with high recurrence rates of 32-88% . To reduce the recurrence rate after pterygium surgery with a bare-sclera technique, various adjunctive modalities have been used such as chemical agents including mitomycin C , 5-fluorouracil . Furthermore, when removal of pterygium is accompanied with a graft, such as conjunctival autograft or amniotic membrane transplantation , lower recurrence rates have been achieved . However, it remains unclear why the bare sclera technique has poorer outcome with higher recurrence rate than other procedures.
Detailed description
One of the factors that may have a role in the outcome of pterygium surgery is postoperative conjunctival inflammation , treatment of which has been demonstrated to improve the final outcome . It has been shown that persistent conjunctival inflammation around the surgical site after pterygium surgery is present in 31-84% of cases with amniotic membrane transplantation, and in 15% of eyes with conjunctival autograft . However, the rate of conjunctival inflammation after pterygium surgery with a bare-sclera technique has not been reported in literature . Also, it has been suggested that higher recurrence rate after pterygium with amniotic membrane transplantation compared with conjunctival autograft may be due to higher rate of postoperative conjunctival inflammation . Therefore, it may be speculated that higher recurrence rate after pterygium surgery with a bare-sclera technique is partly due to higher rate of postoperative conjunctival inflammation .
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| subconjunctival injection of triamcinolone acetonide | Other | Procedure: intraoperative subconjunctival injection of triamcinolone acetonide and limited peritomy during bare scleral pterygium excisionintraoperative subconjunctival injection of triamcinolone acetonide and limited peritomy during bare scleral pterygium excision |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- primary pterygium.
Key exclusion criteria (2 listed)
- preexisting glaucoma .
- patient with family history of glaucoma
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 |
|---|---|---|
| intraoperative subconjunctival injection of triamcinolone acetonide and limited peritomy during bare scleral pterygium excisionintraoperative subconjunctival injection of triamcinolone acetonide and limited peritomy during bare scleral pterygium excision | Procedure or surgery | subconjunctival injection of triamcinolone acetonide |
Primary outcome
the rate of recurrence by grading system of Prabhasawat
Time frame: 6 months
it is a grade to follow up the recurrence of pterygium which classifies pterygium excision outcome from grades 1 to 4: * Grade 1 : indicates a normal appearance of the operated site . * Grade 2 : indicates the presence of fine episcleral vessels in the excised area, extending to the limbus but without any fibrous tissue . * Grade 3 : indicates fibrovascular tissue in the excised area, reaching to the limbus but not invading the cornea and significant conjunctival recurrence . * Grade 4: indicates a true corneal recurrence with fibrovascular tissue invading the cornea.
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 23 Feb 2021.
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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.
Alaa Abdelhafez, Master Degree principal investigator
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intraoperative subconjunctival injection of triamcinolone acetonide and limited peritomy during bare scleral pterygium excision in people with Pterygium, run by Assiut University at 1 site in Egypt.
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 2 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 23 Feb 2021. 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 Egypt. 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 rate of recurrence by grading system of Prabhasawat (time frame: 6 months). 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 23 Feb 2021.