Recurrent PterygiumNCT04463901
Conjunctival Autograft or Limbal Conjunctival Autograft for Recurrent Pterygium Using Mitomycin C
A study testing Pterygium excision, Intraoperative mitomycin C and Conjunctival autograft in people with Recurrent Pterygium, run by Sun Yat-sen University at 1 site in China.
Trial summary
The purpose of this randomized clinical trial is to compare the efficacy and safety of intraoperative mitomycin C(MMC) combined with limbal conjunctival autograft(LCAG) or conjunctival autograft(CAG) for recurrent pterygium surgery. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Recurrent Pterygium
- What is being tested?
- Pterygium excision, Intraoperative mitomycin C and Conjunctival autograft
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteChina
- Study dates
- Feb 2016to Jul 2021
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Recurrent pterygium
- Willingness to participate in research project and to attend research time
- At least 6 months after last pterygium surgery
Who cannot join
- Pregnant,breast-feeding women or poor general health
- Patients with significant ocular or lid pathology, such as Sjogren's Syndrome ,infection, exposure keratitis,glaucoma and trauma
- Patients with allergy to mitomycin C,tobramycin or local anesthetics
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhongshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, Guangdong, 510060
Shiyou Zhou, M.D., Ph.D., 86-02087331550, zhoushiy@mail.sysu.edu.cn
Tao Zhou, M.D.
About this study
Official title: Intraoperative Mitomycin C Combined With Conjunctival Autograft or Limbal Conjunctival Autograft for Recurrent Pterygium: a Randomized Clinical Trial
The purpose of this randomized clinical trial is to compare the efficacy and safety of intraoperative mitomycin C(MMC) combined with limbal conjunctival autograft(LCAG) or conjunctival autograft(CAG) for recurrent pterygium surgery. The investigators will also evaluate particular risk factors related to pterygium recurrence
Read the detailed description
Intraoperative mitomycin C after pterygium excision is widely used to prevent recurrce of recurrent pterygium. Conjunctival autograft with or without limbal tissue used to cover the bare sclera will efficiently reduce postoperative longstanding epithelial defect.
Patients with recurrent pterygium will be randomly assigned to undertake pterygium excision followed by intraoperative mitomycin C with conjunctival autograft or limbal conjunctival autograft .The patients will be followed at least 12 months. Corneal recurrence is considered as a fibrovascular ingrowth beyond the limbus with conjunctival drag in the area of previous pterygium excision.
- Conditions
- Recurrent Pterygium
- Being tested
- Pterygium excision, Intraoperative mitomycin C, Conjunctival autograft, Limbal conjunctival autograft
- Keywords
- recurrent pterygium, pterygium, limbal conjunctival autograft, conjunctival autograft, mitomycin c
- Medical subject headings
- Pterygium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pterygium excisionProcedure or surgery
Partial conjunctiva and anterior tenon's membrane underneath will be removed after the excision of pterygium tissue.
Intraoperative mitomycin CProcedure or surgery
Also called MMC
Intraoperative mitomycin C (0.02%) will be applied for 5 minutes after pterygium excision.
Conjunctival autograftProcedure or surgery
Also called CAG
A conjunctival autograft will be applied to cover the conjunctival defect after pterygium excision.
Limbal conjunctival autograftProcedure or surgery
Also called LCAG
A limbal conjunctival autograft will be applied to cover the conjunctival defect after pterygium excision.
| Study group | Role | What they receive |
|---|---|---|
| Group CAG | Active comparator | After pterygium excision, intraoperative mitomycin c (0.02%) for 5 minutes will be applied topically onto the exposed surgical area and then conjunctival autograft without limbal tissue will be used to cover the bare sclera. Receives: Procedure: Pterygium excision; Procedure: Intraoperative mitomycin C; Procedure: Conjunctival autograft |
| Group LCAG | Active comparator | After pterygium excision, intraoperative mitomycin c (0.02%) for 5 minutes will be applied topically onto the exposed surgical area and then limbal conjunctival autograft will be used to cover the bare sclera. Receives: Procedure: Pterygium excision; Procedure: Intraoperative mitomycin C; Procedure: Limbal conjunctival autograft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence of pterygium
Measured: One year
Secondary outcomes (4)
Visual acuity
Measured: One year
Healing time of corneal epithelium
Measured: Four weeks
Healing time of conjunctival epithelium
Measured: Four weeks
Postoperative complications
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2020
- Study startFeb 2016
- Primary completionJul 2021 (estimated)
- Study completionJul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent PterygiumStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 116 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shiyou Zhou, Sun Yat-sen University
- Investigators
- Zhou Shiyou, M.D., Ph.D., Principal investigator, Zhongshan Ophthalmic Center, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04463901
- Sponsor's protocol ID
- 20150527
- Status last verified
- Jul 2020
- First submitted
- 4 Jul 2020
- Last updated
- 9 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Mitomycin C Combined With Conjunctival Autograft or Limbal Conjunctival Autograft for Recurrent Pterygium: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04463901
- Acronym / sponsor ID
- 20150527
- Conditions
- Recurrent Pterygium
- Keywords
- recurrent pterygium, pterygium, limbal conjunctival autograft, conjunctival autograft, mitomycin c
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 116 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- Jul 2021 (estimated)
- Study completion
- Jul 2021 (estimated)
- First posted
- 9 Jul 2020 (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.
The purpose of this randomized clinical trial is to compare the efficacy and safety of intraoperative mitomycin C(MMC) combined with limbal conjunctival autograft(LCAG) or conjunctival autograft(CAG) for recurrent pterygium surgery. The investigators will also evaluate particular risk factors related to pterygium recurrence
Detailed description
Intraoperative mitomycin C after pterygium excision is widely used to prevent recurrce of recurrent pterygium. Conjunctival autograft with or without limbal tissue used to cover the bare sclera will efficiently reduce postoperative longstanding epithelial defect.
Patients with recurrent pterygium will be randomly assigned to undertake pterygium excision followed by intraoperative mitomycin C with conjunctival autograft or limbal conjunctival autograft .The patients will be followed at least 12 months. Corneal recurrence is considered as a fibrovascular ingrowth beyond the limbus with conjunctival drag in the area of previous pterygium excision.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group CAG | Active comparator | Procedure: Pterygium excision, Procedure: Intraoperative mitomycin C, Procedure: Conjunctival autograftAfter pterygium excision, intraoperative mitomycin c (0.02%) for 5 minutes will be applied topically onto the exposed surgical area and then conjunctival autograft without limbal tissue will be used to cover the bare sclera. |
| Group LCAG | Active comparator | Procedure: Pterygium excision, Procedure: Intraoperative mitomycin C, Procedure: Limbal conjunctival autograftAfter pterygium excision, intraoperative mitomycin c (0.02%) for 5 minutes will be applied topically onto the exposed surgical area and then limbal conjunctival autograft will be used to cover the bare sclera. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Recurrent pterygium
- Willingness to participate in research project and to attend research time
- At least 6 months after last pterygium surgery
Key exclusion criteria (3 listed)
- Pregnant,breast-feeding women or poor general health
- Patients with significant ocular or lid pathology, such as Sjogren's Syndrome ,infection, exposure keratitis,glaucoma and trauma
- Patients with allergy to mitomycin C,tobramycin or local anesthetics
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 excisionPartial conjunctiva and anterior tenon's membrane underneath will be removed after the excision of pterygium tissue. | Procedure or surgery | Group CAG, Group LCAG |
| Intraoperative mitomycin CAlso: MMCIntraoperative mitomycin C (0.02%) will be applied for 5 minutes after pterygium excision. | Procedure or surgery | Group CAG, Group LCAG |
| Conjunctival autograftAlso: CAGA conjunctival autograft will be applied to cover the conjunctival defect after pterygium excision. | Procedure or surgery | Group CAG |
| Limbal conjunctival autograftAlso: LCAGA limbal conjunctival autograft will be applied to cover the conjunctival defect after pterygium excision. | Procedure or surgery | Group LCAG |
Primary outcome
Recurrence of pterygium
Time frame: One year
4 secondary outcomes
Visual acuity
Time frame: One year
Healing time of corneal epithelium
Time frame: Four weeks
Healing time of conjunctival epithelium
Time frame: Four weeks
Postoperative complications
Time frame: One year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2020.
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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.
Zhou Shiyou, M.D., Ph.D. principal investigator
Zhongshan Ophthalmic Center, Sun Yat-sen 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 Pterygium excision, Intraoperative mitomycin C and Conjunctival autograft in people with Recurrent Pterygium, run by Sun Yat-sen University at 1 site in China.
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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 9 Jul 2020. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhou Shiyou, M.D., Ph.D. (86-02087331540, zhoushiy@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence of pterygium (time frame: One 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 9 Jul 2020.