An interventional study of Micro-Conjunctival Autograft Combined with Amniotic Membrane Transplantation and Conventional Autologous Conjunctival Transplantation in Recurrent Pterygium and Micro-Conjunctival Autografting Combined With Amniotic Membrane Transplantation, sponsored by Yifeng Yu. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-05-05.
Sponsored by Yifeng Yu · Not applicable, Interventional, and Treatment
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.
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.
109 studies on the registry are indexed under Pterygium; 9 are open to participants now.
This study's enrollment of 40 is below the median of 60 across 93 interventional studies indexed under Pterygium.
Browse Pterygium studies →Yifeng Yu is the lead sponsor of 4 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The experimental group received micro-conjunctival autograft combined with amniotic membrane transplantation.
Procedure: Micro-Conjunctival Autograft Combined with Amniotic Membrane Transplantation
The control group received given routine autologous conjunctival transplantation.
Procedure: Conventional Autologous Conjunctival Transplantation
1. 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.
1. 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.
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).
Time frame: Day 0#3#7 and14, Month 1#3 and 6.
Changes of Schirmer test I
5-minute Schirmer test I
Time frame: 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.
Time frame: Day 0#3#7 and14, Month 1#3 and 6.
Changes of corneal epithelial repair time
Corneal fluorescein sodium staining was applied to assess the epithelial repair after operation.
Time frame: Day 0#3#7 and14, Month 1#3 and 6.
Changes of visual acuity
To observe the changes of visual acuity around operation.
Time frame: Day 0#3#7 and14, Month 1#3 and 6.
Changes of pterygium size
The pterygium size is recorded by the longest length of its invasion into the cornea.
Time frame: Day 0#3#7 and14, Month 1#3 and 6.
Changes of intraocular pressure
To monitor intraocular pressure during the period of useing glucocorticoids.
Time frame: Day 0#3#7 and14, Month 1#3 and 6.
Plan to share: No
No publications or documents are linked to this record.
Ran from Mar 2021 to primary completion in May 2021, 2 months.
Of 18 interventional studies with no phase under Pterygium, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 28. This study's 2 months is below that.
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This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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