Recurrent Pterygium
Conditions
Keywords
Amniotic membrane, Limbal conjunctival autograft, Limbal, Conjunctival, Mitomycin C, Recurrent pterygium, Pterygium
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREMMC
Intraoperative 0.2mg/ml mitomycin C (0.02%) for 3 minutes will be applied topically after extensive excision of recurrent pterygium.
PROCEDURELCAG
Limbal conjunctival autograft transplantation will be applied to closure of conjunctival defect after extensive excision of recurrent pterygium.
PROCEDUREAMG
Amniotic membrane graft transplantation will be applied to closure of conjunctival defect after extensive excision of recurrent pterygium.
Sponsors
Shiyou Zhou
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* The patients had one or two eye(s) with unilateral recurrent pterygium. * Recurrent pterygium：be defined as of fibrovascular tissue onto the cornea for any distance in the position of a previous pterygium. * Willingness to participate in research project and to attend research time.
Exclusion criteria
* Poor general health. * Pregnant or lactating women. * Patients with collagen vascular diseases or other autoimmune diseases. * Patients with any evidence of stem cell deficiency. * Patients with glaucoma who might require future filtering surgery. * Patients with ocular infection. * Patients with an allergy to mitomycin C, tobramycin or dexamethasone.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recurrence | One Year | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complications | One year | — |
| Healing Time of Corneal Epithelial Defect | Four Weeks | — |
| Eye Movement Amplitude (EMA) | One Year | — |
| Postoperative Conjunctival Inflammation | One month | 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). |
Countries
China
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 47 |
| 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. | 42 |
| Total | 89 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 6 |
Baseline characteristics
| Characteristic | Group LCAG | Group AMG | Total |
|---|---|---|---|
| Age, Continuous | 53.1 years STANDARD_DEVIATION 12.2 | 55.3 years STANDARD_DEVIATION 11.5 | 54.1 years STANDARD_DEVIATION 11.8 |
| Region of Enrollment China | 47 eyes | 42 eyes | 89 eyes |
| Sex: Female, Male Female | 27 Participants | 22 Participants | 49 Participants |
| Sex: Female, Male Male | 20 Participants | 20 Participants | 40 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 9 / 47 | 7 / 40 |
| serious Total, serious adverse events | 0 / 47 | 0 / 40 |
Outcome results
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.
Time frame: One Year
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group LCAG | Recurrence | Grade A | 46 eyes |
| Group LCAG | Recurrence | Grade B | 0 eyes |
| Group LCAG | Recurrence | Grade C | 0 eyes |
| Group LCAG | Recurrence | Grade D (recurrence) | 1 eyes |
| Group AMG | Recurrence | Grade D (recurrence) | 3 eyes |
| Group AMG | Recurrence | Grade A | 34 eyes |
| Group AMG | Recurrence | Grade C | 2 eyes |
| Group AMG | Recurrence | Grade B | 3 eyes |
p-value: <0.05Wilcoxon (Mann-Whitney)
Secondary
Complications
Time frame: One year
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group LCAG | Complications | 9 eyes |
| Group AMG | Complications | 8 eyes |
p-value: <0.05Chi-squared
Secondary
Eye Movement Amplitude (EMA)
Time frame: One Year
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group LCAG | Eye Movement Amplitude (EMA) | Preoperative EMA | 6.67 millimeter | Standard Deviation 1.84 |
| Group LCAG | Eye Movement Amplitude (EMA) | Postoperative EMA | 8.35 millimeter | Standard Deviation 1.38 |
| Group LCAG | Eye Movement Amplitude (EMA) | Improvement of EMA | 1.67 millimeter | Standard Deviation 1.77 |
| Group AMG | Eye Movement Amplitude (EMA) | Preoperative EMA | 6.79 millimeter | Standard Deviation 2.01 |
| Group AMG | Eye Movement Amplitude (EMA) | Postoperative EMA | 7.85 millimeter | Standard Deviation 1.94 |
| Group AMG | Eye Movement Amplitude (EMA) | Improvement of EMA | 1.06 millimeter | Standard Deviation 1.84 |
p-value: <0.05t-test, 2 sided
Secondary
Healing Time of Corneal Epithelial Defect
Time frame: Four Weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group LCAG | Healing Time of Corneal Epithelial Defect | 2.78 days | Standard Deviation 0.73 |
| Group AMG | Healing Time of Corneal Epithelial Defect | 3.25 days | Standard Deviation 2.76 |
p-value: 0.05Wilcoxon (Mann-Whitney)
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).
Time frame: One month
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group LCAG | Postoperative Conjunctival Inflammation | Grade 0 | 21 eyes |
| Group LCAG | Postoperative Conjunctival Inflammation | Grade i | 17 eyes |
| Group LCAG | Postoperative Conjunctival Inflammation | Grade ii | 9 eyes |
| Group LCAG | Postoperative Conjunctival Inflammation | Grade iii | 0 eyes |
| Group AMG | Postoperative Conjunctival Inflammation | Grade iii | 1 eyes |
| Group AMG | Postoperative Conjunctival Inflammation | Grade 0 | 14 eyes |
| Group AMG | Postoperative Conjunctival Inflammation | Grade ii | 13 eyes |
| Group AMG | Postoperative Conjunctival Inflammation | Grade i | 14 eyes |
p-value: <0.05Wilcoxon (Mann-Whitney)