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To compare the outcomes of limbal conjunctival autograft (LCAG) versus amniotic membrane graft (AMG) when combined with intraoperative 0.02% mitomycin C (MMC) after pterygium removal in patients with recurrent pterygium.
Excision alone for treating recurrent pterygium was reported to be at risk of high recurrence again. As one of adjunctive methods, intraoperative application of a single dose of mitomycin C (MMC) seems to be the most commonly used method for preventing recurrence of pterygium. Additionally, closure of conjunctival defect after excision of pterygium by limbal conjunctival autograft or amniotic membrane have also become popular in recent years. There are a few reports in which MMC combined either limbal conjunctival autograft (LCAG) or amniotic membrane graft (AMG) for the treatment of recurrent pterygium. To assess the effectiveness and safety of these two combined approaches, the investigator plans to work on a randomized comparative and prospective trial of recurrent pterygium extensive excision with intraoperative 0.02% MMC application comparing LCAG to AMG.The patients enrolled in this study will be followed for at least 12 months after the surgery. Recurrence was defined as fibrovascular tissue crossing the limbus on to the clear cornea in the area of previous pterygium excision.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group LCAG | Active Comparator | After extensive excision of recurrent pterygium, intraoperative 0.2 mg/ml MMC (0.02%) for 3 minutes will be applied topically onto the exposed surgical area and then limbal conjunctival autograft for repairing the conjunctival defect. |
|
| Group AMG | Active Comparator | After excision of recurrent pterygium, intraoperative 0.2 mg/ml MMC (0.02%) for 3 minutes will be applied topically onto the exposed surgical area and then an amniotic membrane graft for repairing the conjunctival defect. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MMC | Procedure | Intraoperative 0.2mg/ml mitomycin C (0.02%) for 3 minutes will be applied topically after extensive excision of recurrent pterygium. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence | Recurrence was defined as the presence of fibrovascular tissue in the surgical area and invasion onto the cornea. The appearance of the surgical bed in successful cases was graded as follows: grade A was defined as the operated eye being indistinguishable from a normal eye, grade B was defined as the presence of fine episcleral vessels without fibrous tissue in the surgical area extending up to the limbus but not beyond, and grade C was defined as the presence of fibrovascular tissue in the surgical area but without invasion onto the cornea. | One Year |
| Measure | Description | Time Frame |
|---|---|---|
| Complications | One year | |
| Healing Time of Corneal Epithelial Defect | Four Weeks | |
| Eye Movement Amplitude (EMA) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shiyou Zhou, MD, PHD | Zhongshan Ophthalmic Center, Sun Yat-sen University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University | Guangzhou | Guangdong | 510060 | China |
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The patients, who had one or two eye(s) with unilateral recurrent pterygium, were consecutively recruited from Zhongshan Ophthalmic Center, Guangzhou, between December 2010 and May 2013. In cases of bilateral eyes with recurrent pterygium, the left eye was the first to be assigned randomly, followed by the right eye.
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| ID | Title | Description |
|---|---|---|
| FG000 | Group LCAG | After excision of recurrent pterygium, intraoperative 0.2 mg/ml mitomycin C (0.02%) for 3 minutes will be applied topically onto the exposed surgical area and then limbal conjunctival autograft for repairing the conjunctival defect. |
| FG001 | Group AMG | After excision of recurrent pterygium, intraoperative 0.2 mg/ml mitomycin C (0.02%) for 3 minutes will be applied topically onto the exposed surgical area and then an amniotic membrane graft for repairing the conjunctival defect. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
No significant difference of the baseline characteristics was observed between the per-protocol population (n=89 eyes) and the randomized population (n=96 eyes), and there was no significant bias due to patients dropout. Therefore, the baseline participants for analysis were observed in the per-protocol population.
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| ID | Title | Description |
|---|---|---|
| BG000 | Group LCAG | After excision of recurrent pterygium, intraoperative 0.2 mg/ml mitomycin C (0.02%) for 3 minutes will be applied topically onto the exposed surgical area and then limbal conjunctival autograft for repairing the conjunctival defect. |
| BG001 | Group AMG |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Recurrence | Recurrence was defined as the presence of fibrovascular tissue in the surgical area and invasion onto the cornea. The appearance of the surgical bed in successful cases was graded as follows: grade A was defined as the operated eye being indistinguishable from a normal eye, grade B was defined as the presence of fine episcleral vessels without fibrous tissue in the surgical area extending up to the limbus but not beyond, and grade C was defined as the presence of fibrovascular tissue in the surgical area but without invasion onto the cornea. | Posted | Number | eyes | One Year | eyes | Participants |
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group LCAG | After excision of recurrent pterygium, intraoperative 0.2 mg/ml mitomycin C (0.02%) for 3 minutes will be applied topically onto the exposed surgical area and then limbal conjunctival autograft for repairing the conjunctival defect. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Punctate epithelial keratitis | Eye disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Shiyou Zhou | State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University | +86-020-87331540 | zhoushiy@mail.sysu.edu.cn |
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| ID | Term |
|---|---|
| D011625 | Pterygium |
| ID | Term |
|---|---|
| D003229 | Conjunctival Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D016685 | Mitomycin |
| ID | Term |
|---|---|
| D008937 | Mitomycins |
| D045563 | Indolequinones |
| D011809 | Quinones |
| D009930 | Organic Chemicals |
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| LCAG | Procedure | Limbal conjunctival autograft transplantation will be applied to closure of conjunctival defect after extensive excision of recurrent pterygium. |
|
|
| AMG | Procedure | Amniotic membrane graft transplantation will be applied to closure of conjunctival defect after extensive excision of recurrent pterygium. |
|
|
| One Year |
| Postoperative Conjunctival Inflammation | The presence of conjunctival inflammation around the surgical site was assessed at 4 weeks post-operatively and graded as 0 (none), i (mild), ii (moderate), and iii (severe). | One month |
After excision of recurrent pterygium, intraoperative 0.2 mg/ml mitomycin C (0.02%) for 3 minutes will be applied topically onto the exposed surgical area and then an amniotic membrane graft for repairing the conjunctival defect. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | eyes |
|
| OG001 |
| Group AMG |
After excision of recurrent pterygium, intraoperative 0.2 mg/ml mitomycin C (0.02%) for 3 minutes will be applied topically onto the exposed surgical area and then an amniotic membrane graft for repairing the conjunctival defect. |
|
|
|
| Secondary | Complications | Posted | Number | eyes | One year | eyes | Participants |
|
|
|
|
| Secondary | Healing Time of Corneal Epithelial Defect | Posted | Mean | Standard Deviation | days | Four Weeks | eyes | Participants |
|
|
|
|
| Secondary | Eye Movement Amplitude (EMA) | Posted | Mean | Standard Deviation | millimeter | One Year | eyes | Participants |
|
|
|
|
| Secondary | Postoperative Conjunctival Inflammation | The presence of conjunctival inflammation around the surgical site was assessed at 4 weeks post-operatively and graded as 0 (none), i (mild), ii (moderate), and iii (severe). | Posted | Number | eyes | One month | eyes | Participants |
|
|
|
|
| 0 |
| 47 |
| 9 |
| 47 |
| EG001 | Group AMG | After excision of recurrent pterygium, intraoperative 0.2 mg/ml mitomycin C (0.02%) for 3 minutes will be applied topically onto the exposed surgical area and then an amniotic membrane graft for repairing the conjunctival defect. | 0 | 40 | 7 | 40 |
| Local episcleral melting | Eye disorders | Non-systematic Assessment |
|
| Localized pannus at donor site | Eye disorders | Non-systematic Assessment |
|
| Delayed epithelializaiton of corneal defect | Eye disorders | Non-systematic Assessment |
|
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| D001389 |
| Azirines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| Improvement of EMA |
|
| Grade ii |
|
| Grade iii |
|