Recurrent PterygiumNCT05362253
Micro-Conjunctival Autografting Combined With Amniotic Membrane Transplantation Treating Recurrent Pterygium Trial
A study testing Micro-Conjunctival Autograft Combined with Amniotic Membrane Transplantation and Conventional Autologous Conjunctival Transplantation in people with Recurrent Pterygium and Micro-Conjunctival Autografting Combined With Amniotic Membrane Transplantation, run by Yifeng Yu at 1 site in China.
Trial summary
To observe the effect of micro-conjunctival autografting combined with amniotic membrane transplantation on the postoperative recurrence, complications and ocular surface symptoms among patients with recurrent pterygium. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrent Pterygium, Micro-Conjunctival Autografting Combined With Amniotic Membrane Transplantation
- What is being tested?
- Micro-Conjunctival Autograft Combined with Amniotic Membrane Transplantation and Conventional Autologous Conjunctival Transplantation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2021to 10 Dec 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age⩾18;
- relapsed after pterygium surgery once;
- invading the cornea 2.00~5.00mm.
Who cannot join
- having obvious severe systemic organic diseases and mental diseases;
- In lactation or pregnancy or planned pregnancy;
- combined with eye diseases such as severe eyelid insufficiency, dry eye, chemical injury of cornea and conjunctiva, etc.;
- used drugs that may affect the growth and metabolism of corneal epithelium within four weeks before inclusion in the study;
- received pterygium surgery twice or more.
Trial locations and contacts
1 site in 1 country.
China1 site
the Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330000
About this study
Official title: The Effect of Micro-Conjunctival Autografting Combined With Amniotic Membrane Transplantation on Treating Recurrent Pterygium: A Non-randomized Controlled Trial
To observe the effect of micro-conjunctival autografting combined with amniotic membrane transplantation on the postoperative recurrence, complications and ocular surface symptoms among patients with recurrent pterygium.
Read the detailed description
Recurrent pterygium is a common postoperative complication of pterygium surgery, the postoperative recurrence rate is about 1.44% and needs careful treatment. At present, surgical is the main and most effective treatment of recurrent pterygium. Among various surgical methods, autologous conjunctival transplantation is regarded as the first choice in normal conditions. However, the scope of conjunctival transplantation is positively correlated with the degree of ocular surface damage. Therefore, our research aimed to use micro conjunctival transplantation（1.5mm×3.0mm） to reconstruct limbal conjunctiva and amniotic membrane to cover the whole pterygium resection area to better protect conjunctival sac and ocular surface.
- Conditions
- Recurrent Pterygium, Micro-Conjunctival Autografting Combined With Amniotic Membrane Transplantation
- Being tested
- Micro-Conjunctival Autograft Combined with Amniotic Membrane Transplantation, Conventional Autologous Conjunctival Transplantation
- Keywords
- Recurrent pterygium, Conjunctival flap, Transplantation
- Medical subject headings
- Pterygium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Micro-Conjunctival Autograft Combined with Amniotic Membrane TransplantationProcedure or surgery
- Disinfection, anaesthesia and excision of recurrent pterygium are the same as conventional autologous conjunctival transplantation.
- The biological freeze-dried amniotic membrane (Jiangxi Ruiji Biological engineering technology Co., Ltd., Nanchang, China), equivalent in size to the exposed scleral surface, was flat mounted on the exposed scleral area , and the amniotic membrane was fixed on the superficial sclera with 10-0 suture.
- After amniotic membrane graft was fixed, 2% lidocaine was applied to the superior temporal conjunctiva.
- Take the conjunctival epithelial graft with the length equivalent to the neck of recurrent pterygium and the width of 1.5mm ~ 2.0mm, and translate it on amniotic membrane surface near corneal limbus. The conjunctival flap was secured with 10-0 suture.
- Last, tobramycin and dexamethasone eye ointment was applied and bandaged with dressing.
Conventional Autologous Conjunctival TransplantationProcedure or surgery
- Routine disinfection and anaesthesia.
- To bluntly separate and excise pterygium.
- Remove pterygium tissue on the corneal surface with a round blade.
- Place a cotton ball slightly infiltrated with diluent Bleomycin A5 Hydrochloride for Injection on the exposed sclera for 1 minute and flushed away later.
- After anesthesia, take the superior temporal conjunctival epithelium equal to the size of the exposed scleral and translate it to the exposed scleral surface (the limbus side of the graft corresponds to the limbus of the graft bed), and fixed with 10-0 suture.
- The free conjunctival margin of the conjunctival flap sampling area was sutured intermittently with 10-0 suture.
- Apply tobramycin dexamethasone eye ointment and wrap the eyes with dressing after operation.
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | The experimental group received micro-conjunctival autograft combined with amniotic membrane transplantation. Receives: Procedure: Micro-Conjunctival Autograft Combined with Amniotic Membrane Transplantation |
| control group | Active comparator | The control group received given routine autologous conjunctival transplantation. Receives: Procedure: Conventional Autologous Conjunctival Transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of grade of conjunctival hyperplasia
Grade 1, no significant difference from normal eyes (no recurrence); Grade 2, a little episcleral vessels in the pterygium excision area, which extends to the corneoscleral limbus but does not exceed, and there is no fibrous tissue hyperplasia (no recurrence); Grade 3, having proliferative fibrous tissue in the resection area, which does not exceed the limbus (no recurrence); Grade 4, the cornea is invaded by proliferative fibrous tissue, and this grade is true pterygium recurrence (recurrence).
Measured: Day 0#3#7 and14, Month 1#3 and 6.
Changes of Schirmer test I
5-minute Schirmer test I
Measured: Day 0#3#7 and14, Month 1#3 and 6.
Changes of ocular surface symptom scores
Include dryness, burning, foreign body and pain sensation. The full score of each symptom is 100 points, with a score of 0 reflecting no discomfort, 100 was considered as the maximum discomfort.
Measured: Day 0#3#7 and14, Month 1#3 and 6.
Secondary outcomes (2)
Changes of corneal epithelial repair time
Corneal fluorescein sodium staining was applied to assess the epithelial repair after operation.
Measured: Day 0#3#7 and14, Month 1#3 and 6.
Changes of visual acuity
To observe the changes of visual acuity around operation.
Measured: Day 0#3#7 and14, Month 1#3 and 6.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2022
- Study start1 Mar 2021
- Primary completion30 May 2021
- Study completion10 Dec 2021
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.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yifeng Yu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yifeng Yu, Second Affiliated Hospital of Nanchang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05362253
- Sponsor's protocol ID
- [2021]NO.(024)
- Status last verified
- May 2022
- First submitted
- 26 Apr 2022
- Last updated
- 5 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Micro-Conjunctival Autografting Combined With Amniotic Membrane Transplantation on Treating Recurrent Pterygium: A Non-randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05362253
- Acronym / sponsor ID
- [2021]NO.(024)
- Conditions
- Recurrent Pterygium, Micro-Conjunctival Autografting Combined With Amniotic Membrane Transplantation
- Keywords
- Recurrent pterygium, Conjunctival flap, Transplantation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Yifeng YuUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 30 May 2021 (actual)
- Study completion
- 10 Dec 2021 (actual)
- First posted
- 5 May 2022 (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.
To observe the effect of micro-conjunctival autografting combined with amniotic membrane transplantation on the postoperative recurrence, complications and ocular surface symptoms among patients with recurrent pterygium.
Detailed description
Recurrent pterygium is a common postoperative complication of pterygium surgery, the postoperative recurrence rate is about 1.44% and needs careful treatment. At present, surgical is the main and most effective treatment of recurrent pterygium. Among various surgical methods, autologous conjunctival transplantation is regarded as the first choice in normal conditions. However, the scope of conjunctival transplantation is positively correlated with the degree of ocular surface damage. Therefore, our research aimed to use micro conjunctival transplantation（1.5mm×3.0mm） to reconstruct limbal conjunctiva and amniotic membrane to cover the whole pterygium resection area to better protect conjunctival sac and ocular surface.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Procedure: Micro-Conjunctival Autograft Combined with Amniotic Membrane TransplantationThe experimental group received micro-conjunctival autograft combined with amniotic membrane transplantation. |
| control group | Active comparator | Procedure: Conventional Autologous Conjunctival TransplantationThe control group received given routine autologous conjunctival transplantation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age⩾18;
- relapsed after pterygium surgery once;
- invading the cornea 2.00~5.00mm.
Key exclusion criteria (5 listed)
- having obvious severe systemic organic diseases and mental diseases;
- In lactation or pregnancy or planned pregnancy;
- combined with eye diseases such as severe eyelid insufficiency, dry eye, chemical injury of cornea and conjunctiva, etc.;
- used drugs that may affect the growth and metabolism of corneal epithelium within four weeks before inclusion in the study;
- received pterygium surgery twice or more.
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 |
|---|---|---|
| Micro-Conjunctival Autograft Combined with Amniotic Membrane Transplantation1. Disinfection, anaesthesia and excision of recurrent pterygium are the same as conventional autologous conjunctival transplantation. 2. The biological freeze-dried amniotic membrane (Jiangxi Ruiji Biological engineering technology Co., Ltd., Nanchang, China), equivalent in size to the exposed scleral surface, was flat mounted on the exposed scleral area , and the amniotic membrane was fixed on the superficial sclera with 10-0 suture. 3. After amniotic membrane graft was fixed, 2% lidocaine was applied to the superior temporal conjunctiva. 4. Take the conjunctival epithelial graft with the length equivalent to the neck of recurrent pterygium and the width of 1.5mm ~ 2.0mm, and translate it on amniotic membrane surface near corneal limbus. The conjunctival flap was secured with 10-0 suture. 5. Last, tobramycin and dexamethasone eye ointment was applied and bandaged with dressing. | Procedure or surgery | experimental group |
| Conventional Autologous Conjunctival Transplantation1. Routine disinfection and anaesthesia. 2. To bluntly separate and excise pterygium. 3. Remove pterygium tissue on the corneal surface with a round blade. 4. Place a cotton ball slightly infiltrated with diluent Bleomycin A5 Hydrochloride for Injection on the exposed sclera for 1 minute and flushed away later. 5. After anesthesia, take the superior temporal conjunctival epithelium equal to the size of the exposed scleral and translate it to the exposed scleral surface (the limbus side of the graft corresponds to the limbus of the graft bed), and fixed with 10-0 suture. 6. The free conjunctival margin of the conjunctival flap sampling area was sutured intermittently with 10-0 suture. 7. Apply tobramycin dexamethasone eye ointment and wrap the eyes with dressing after operation. | Procedure or surgery | control group |
Primary outcome
Changes of grade of conjunctival hyperplasia
Time frame: Day 0#3#7 and14, Month 1#3 and 6.
Grade 1, no significant difference from normal eyes (no recurrence); Grade 2, a little episcleral vessels in the pterygium excision area, which extends to the corneoscleral limbus but does not exceed, and there is no fibrous tissue hyperplasia (no recurrence); Grade 3, having proliferative fibrous tissue in the resection area, which does not exceed the limbus (no recurrence); Grade 4, the cornea is invaded by proliferative fibrous tissue, and this grade is true pterygium recurrence (recurrence).
Changes of Schirmer test I
Time frame: Day 0#3#7 and14, Month 1#3 and 6.
5-minute Schirmer test I
Changes of ocular surface symptom scores
Time frame: Day 0#3#7 and14, Month 1#3 and 6.
Include dryness, burning, foreign body and pain sensation. The full score of each symptom is 100 points, with a score of 0 reflecting no discomfort, 100 was considered as the maximum discomfort.
2 secondary outcomes
Changes of corneal epithelial repair time
Time frame: Day 0#3#7 and14, Month 1#3 and 6.
Changes of visual acuity
Time frame: Day 0#3#7 and14, Month 1#3 and 6.
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 5 May 2022.
- Individual participant dataSharing planned: No
Related trials for Recurrent Pterygium
Not yet recruiting
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Micro-Conjunctival Autograft Combined with Amniotic Membrane Transplantation and Conventional Autologous Conjunctival Transplantation in people with Recurrent Pterygium and Micro-Conjunctival Autografting Combined With Amniotic Membrane Transplantation, run by Yifeng Yu 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 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 5 May 2022. 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?
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?
Changes of grade of conjunctival hyperplasia (time frame: Day 0#3#7 and14, Month 1#3 and 6.). The study lists 3 primary outcomes in all. 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 5 May 2022.