Recurrent Pterygium Clinical Trial
Official title:
The Effect of Micro-Conjunctival Autografting Combined With Amniotic Membrane Transplantation on Treating Recurrent Pterygium: A Non-randomized Controlled Trial
Verified date | May 2022 |
Source | Second Affiliated Hospital of Nanchang University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 40 |
Est. completion date | December 10, 2021 |
Est. primary completion date | May 30, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. age?18; 2. relapsed after pterygium surgery once; 3. invading the cornea 2.00~5.00mm. Exclusion Criteria: 1. having obvious severe systemic organic diseases and mental diseases; 2. In lactation or pregnancy or planned pregnancy; 3. combined with eye diseases such as severe eyelid insufficiency, dry eye, chemical injury of cornea and conjunctiva, etc.; 4. used drugs that may affect the growth and metabolism of corneal epithelium within four weeks before inclusion in the study; 5. received pterygium surgery twice or more. |
Country | Name | City | State |
---|---|---|---|
China | the Second Affiliated Hospital of Nanchang University | Nanchang | Jiangxi |
Lead Sponsor | Collaborator |
---|---|
Yifeng Yu |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Changes of pterygium size | The pterygium size is recorded by the longest length of its invasion into the cornea. | Day 0#3#7 and14, Month 1#3 and 6. | |
Other | Changes of intraocular pressure | To monitor intraocular pressure during the period of useing glucocorticoids. | Day 0#3#7 and14, Month 1#3 and 6. | |
Primary | 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). | Day 0#3#7 and14, Month 1#3 and 6. | |
Primary | Changes of Schirmer test I | 5-minute Schirmer test I | Day 0#3#7 and14, Month 1#3 and 6. | |
Primary | 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. | Day 0#3#7 and14, Month 1#3 and 6. | |
Secondary | Changes of corneal epithelial repair time | Corneal fluorescein sodium staining was applied to assess the epithelial repair after operation. | Day 0#3#7 and14, Month 1#3 and 6. | |
Secondary | Changes of visual acuity | To observe the changes of visual acuity around operation. | Day 0#3#7 and14, Month 1#3 and 6. |
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