PterygiumNCT03217500
Corneal Epithelial Autograft for Pterygium
A study testing Corneal epithelial autograft, Limbal conjunctival autograft and Simple removal in people with Pterygium, run by Chunxiao Wang at 1 site in China.
Trial summary
The purpose of the study is to explore whether femtosecond laser-assisted cornea epithelial autograft is more effective than limbal conjunctival autograft for ocular surface reconstruction after excision of pterygium. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pterygium
- What is being tested?
- Corneal epithelial autograft, Limbal conjunctival autograft and Simple removal
- Type of treatment
- Pill or oral medicine, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteChina
- Study dates
- 20 Jul 2017to 30 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 to 80 years old;
- Primary pterygium, scheduled for elective surgical excision;
- Pterygium encroaching from the nasal side onto the cornea, with less than 180° limbal involvement and without approaching the central visual axis (pupil area);
- Morphologically intact palisades of Vogt in a given limbal region;
- Absence of any one of the following structures in the limbal region underneath the pterygium: (1) epithelial basal cells with dark cytoplasm and reflective cell borders; (2) at least two prominent palisade ridge structures; (3) at least one circular and/or oval-shaped focal stromal projection;
- Informed consent signed by patient or legal guardian; Having the ability to comply with study assessments for the full duration of the study.
Who cannot join
- Limbal stem cell deficiency by ocular surface disorders other than pterygium;
- Inability to determine whether the palisades of Vogt underneath the pterygium is absent or not using in vivo confocal microscopy;
- High myopia with a spherical equivalent of -15.0 D or less;
- Corneal or ocular surface infection within 30 days prior to study entry;
- Ocular surface malignancy;
- Uncontrolled diabetes with most recent Hemoglobin A1c greater than 8.5%;
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- Renal failure with creatinine clearance< 25ml/min;
- Alanine aminotransferase > 40IU/L, or aspartate aminotransferase > 40IU/L;
- Platelet levels < 150,000 or > 450,000 per microliter;
- Hemoglobin < 12.0 g/dL (male) or < 11.0 g/dL (female);
- Prothrombin time > 16s and activated partial thrombin time > 35s in patients not accepting anticoagulant therapy; An international normalized ratio greater than 3 in patients accepting anticoagulant therapy;
- Pregnancy (positive test) or lactation;
- Participation in another simultaneous medical investigation or clinical trial;
- Severe cicatricial eye disease;
- Ocular comorbidities that affect the prognosis of transplantation, such as advanced glaucoma or retinal diseases;
- Severe dry eye disease as determined by Schirmer's test < 2mm at least in one eye;
- Any medical or social condition that in the judgement of the investigator would interfere with or serve as a contraindication to adherence to the study protocol or ability to give informed consent;
- Signs of current infection, including fever and treatment with antibiotics;
- Active immunological diseases;
- History of allo-limbal transplantation, penetrating keratoplasty or anti-glaucoma filtering surgeries.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhongshan Ophthalmic Center, Sun Yat-sen Univerisity
Guangzhou, Guangdong, 510000
Yingfeng Zheng, M.D. Ph.D.
About this study
Official title: A Randomized Controlled Clinical Trial of Corneal Epithelial Autograft for Pterygium
The purpose of the study is to explore whether femtosecond laser-assisted cornea epithelial autograft is more effective than limbal conjunctival autograft for ocular surface reconstruction after excision of pterygium.
- Conditions
- Pterygium
- Being tested
- Corneal epithelial autograft, Limbal conjunctival autograft, Simple removal, Diamond knife, Femtosecond laser
- Medical subject headings
- Pterygium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Corneal epithelial autograftProcedure or surgery
After removal of the recipient's pterygium tissue, a donor epithelial tissue equal in length to the bared limbus, will be obtained from the peripheral epithelial of the same eye (corneal epithelial autograft) using femtosecond laser technology. The epithelial graft will be sutured to the recipient limbal bed, with the goal of reconstruction of palisades of Vogt. The graft will act as a barrier to regrowth of pterygium. The area of the graft will be left with the Tenon capsule exposed.
Limbal conjunctival autograftProcedure or surgery
After removal of the recipient's pterygium tissue, an adjustable diamond knife will be used to create a superficial circumferential incision at the corneal end of the limbal vascular arcade, equal in length to the bared limbus. This will be followed by harvesting the limbal-conjunctival flap. The limbal-conjunctival autograft will be sutured to the recipient bed, with the Tenon capsule exposed. The graft will serve as a barrier to regrowth of pterygium.
Simple removalProcedure or surgery
Simple removal of the recipient's pterygium tissue, with the Tenon capsule exposed.
Diamond knifeDevice
A diamond knife to create a particular shaped limbal graft for transplantation
Femtosecond laserDevice
A commercial femtosecond laser to create a particular shaped graft for transplantation
| Study group | Role | What they receive |
|---|---|---|
| Corneal epithelial autograft | Experimental | pterygium resection combined with femtosecond laser assisted corneal epithelial autograft Receives: Procedure: Corneal epithelial autograft; Device: Femtosecond laser |
| Limbal conjunctival autograft | Active comparator | pterygium resection combined with diamond knife assisted limbal conjunctival autograft Receives: Procedure: Limbal conjunctival autograft; Device: Diamond knife |
| Simple removal | Active comparator | Simple removal of pterygium Receives: Procedure: Simple removal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Restoration of corneal surface
Restoration of a completely epithelized, stable, and avascular corneal surface
Measured: 1 year
Secondary outcomes (5)
Recurrence of pterygium
To observe recurrence of pterygium using slit-lamp microscopy
Measured: 1 year
Reconstruction of palisades of Vogt
To observe the reconstruction of palisades of Vogt using in vivo confocal microscopy.
Measured: 1 year
Best corrected visual acuity
To assess changes of best corrected visual acuity using ETDRS chart
Measured: 1 year
Corneal power and astigmatism
To assess changes of corneal power and astigmatism using autorefractor keratometer
Measured: 1 year
Corneal haze measurement
To observe the scatter of corneal haze using in vivo confocal microscopy
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 posted14 Jul 2017
- Study start20 Jul 2017
- Primary completion30 Dec 2018 (estimated)
- Study completion30 Dec 2019 (estimated)
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chunxiao Wang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Chunxiao Wang, Sun Yat-sen University
- Investigators
- Yizhi Liu, M.D.Ph.D., Principal investigator, Zhongshan Ophthalmic Center, Sun Yat-sen UniversityTing Huang, M.D.Ph.D., Principal investigator, Zhongshan Ophthalmic Center, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03217500
- Sponsor's protocol ID
- 2017KYPJ050
- Status last verified
- Feb 2018
- First submitted
- 12 Jul 2017
- Last updated
- 22 Feb 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Clinical Trial of Corneal Epithelial Autograft for Pterygium
- ClinicalTrials.gov ID
- NCT03217500
- Acronym / sponsor ID
- 2017KYPJ050
- Conditions
- Pterygium
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Chunxiao WangUniversity, hospital or other
- Study start
- 20 Jul 2017 (actual)
- Primary completion
- 30 Dec 2018 (estimated)
- Study completion
- 30 Dec 2019 (estimated)
- First posted
- 14 Jul 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.
The purpose of the study is to explore whether femtosecond laser-assisted cornea epithelial autograft is more effective than limbal conjunctival autograft for ocular surface reconstruction after excision of pterygium.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Corneal epithelial autograft | Experimental | Procedure: Corneal epithelial autograft, Device: Femtosecond laserpterygium resection combined with femtosecond laser assisted corneal epithelial autograft |
| Limbal conjunctival autograft | Active comparator | Procedure: Limbal conjunctival autograft, Device: Diamond knifepterygium resection combined with diamond knife assisted limbal conjunctival autograft |
| Simple removal | Active comparator | Procedure: Simple removalSimple removal of pterygium |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age between 18 to 80 years old;
- Primary pterygium, scheduled for elective surgical excision;
- Pterygium encroaching from the nasal side onto the cornea, with less than 180° limbal involvement and without approaching the central visual axis (pupil area);
- Morphologically intact palisades of Vogt in a given limbal region;
- Absence of any one of the following structures in the limbal region underneath the pterygium: (1) epithelial basal cells with dark cytoplasm and reflective cell borders; (2) at least two prominent palisade ridge structures; (3) at least one circular and/or oval-shaped focal stromal projection;
Key exclusion criteria (20 listed)
- Limbal stem cell deficiency by ocular surface disorders other than pterygium;
- Inability to determine whether the palisades of Vogt underneath the pterygium is absent or not using in vivo confocal microscopy;
- High myopia with a spherical equivalent of -15.0 D or less;
- Corneal or ocular surface infection within 30 days prior to study entry;
- Ocular surface malignancy;
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 |
|---|---|---|
| Corneal epithelial autograftAfter removal of the recipient's pterygium tissue, a donor epithelial tissue equal in length to the bared limbus, will be obtained from the peripheral epithelial of the same eye (corneal epithelial autograft) using femtosecond laser technology. The epithelial graft will be sutured to the recipient limbal bed, with the goal of reconstruction of palisades of Vogt. The graft will act as a barrier to regrowth of pterygium. The area of the graft will be left with the Tenon capsule exposed. | Procedure or surgery | Corneal epithelial autograft |
| Limbal conjunctival autograftAfter removal of the recipient's pterygium tissue, an adjustable diamond knife will be used to create a superficial circumferential incision at the corneal end of the limbal vascular arcade, equal in length to the bared limbus. This will be followed by harvesting the limbal-conjunctival flap. The limbal-conjunctival autograft will be sutured to the recipient bed, with the Tenon capsule exposed. The graft will serve as a barrier to regrowth of pterygium. | Procedure or surgery | Limbal conjunctival autograft |
| Simple removalSimple removal of the recipient's pterygium tissue, with the Tenon capsule exposed. | Procedure or surgery | Simple removal |
| Diamond knifeA diamond knife to create a particular shaped limbal graft for transplantation | Device | Limbal conjunctival autograft |
| Femtosecond laserA commercial femtosecond laser to create a particular shaped graft for transplantation | Device | Corneal epithelial autograft |
Primary outcome
Restoration of corneal surface
Time frame: 1 year
Restoration of a completely epithelized, stable, and avascular corneal surface
5 secondary outcomes
Recurrence of pterygium
Time frame: 1 year
Reconstruction of palisades of Vogt
Time frame: 1 year
Best corrected visual acuity
Time frame: 1 year
Corneal power and astigmatism
Time frame: 1 year
Corneal haze measurement
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2018.
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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.
Yizhi Liu, M.D.Ph.D. principal investigator
Zhongshan Ophthalmic Center, Sun Yat-sen University
Ting Huang, 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 Corneal epithelial autograft, Limbal conjunctival autograft and Simple removal in people with Pterygium, run by Chunxiao Wang 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 6 inclusion and 20 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 22 Feb 2018. 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 Yingfeng Zheng, M.D.Ph.D. (+8613922286455, yingfeng.zheng@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Restoration of corneal surface (time frame: 1 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 22 Feb 2018.