Trial Outcomes & Findings for Recurrent Pterygium Surgery Using Mitomycin C With Limbal Conjunctival or Amniotic Membrane (NCT NCT01319721)

NCT ID: NCT01319721

Last Updated: 2015-03-19

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 96 participants
• Primary outcome timeframe: One Year
• Results posted on: 2015-03-19

Participant Flow

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.

Participant milestones

Measure	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.	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.
Overall Study STARTED	48	48
Overall Study COMPLETED	47	42
Overall Study NOT COMPLETED	1	6

Reasons for withdrawal

Measure	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.	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.
Overall Study Lost to Follow-up	1	6

Baseline Characteristics

Recurrent Pterygium Surgery Using Mitomycin C With Limbal Conjunctival or Amniotic Membrane

Baseline characteristics by cohort

Measure	Group LCAG n=47 Participants 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.	Group AMG n=42 Participants 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.	Total n=89 Participants Total of all reporting groups
Age, Continuous	53.1 years STANDARD_DEVIATION 12.2 • n=5 Participants	55.3 years STANDARD_DEVIATION 11.5 • n=7 Participants	54.1 years STANDARD_DEVIATION 11.8 • n=5 Participants
Sex: Female, Male Female	27 Participants n=5 Participants	22 Participants n=7 Participants	49 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants	20 Participants n=7 Participants	40 Participants n=5 Participants
Region of Enrollment China	47 eyes n=5 Participants	42 eyes n=7 Participants	89 eyes n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Group LCAG n=47 eyes 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.	Group AMG n=42 eyes 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.
Recurrence Grade A	46 eyes	34 eyes
Recurrence Grade D (recurrence)	1 eyes	3 eyes
Recurrence Grade B	0 eyes	3 eyes
Recurrence Grade C	0 eyes	2 eyes

SECONDARY outcome

Timeframe: One year

Outcome measures

Measure	Group LCAG n=47 eyes 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.	Group AMG n=42 eyes 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.
Complications	9 eyes	8 eyes

SECONDARY outcome

Timeframe: Four Weeks

Outcome measures

Measure	Group LCAG n=47 eyes 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.	Group AMG n=42 eyes 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.
Healing Time of Corneal Epithelial Defect	2.78 days Standard Deviation 0.73	3.25 days Standard Deviation 2.76

SECONDARY outcome

Timeframe: One Year

Outcome measures

Measure	Group LCAG n=47 eyes 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.	Group AMG n=42 eyes 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.
Eye Movement Amplitude (EMA) Postoperative EMA	8.35 millimeter Standard Deviation 1.38	7.85 millimeter Standard Deviation 1.94
Eye Movement Amplitude (EMA) Improvement of EMA	1.67 millimeter Standard Deviation 1.77	1.06 millimeter Standard Deviation 1.84
Eye Movement Amplitude (EMA) Preoperative EMA	6.67 millimeter Standard Deviation 1.84	6.79 millimeter Standard Deviation 2.01

SECONDARY outcome

Timeframe: 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).

Outcome measures

Measure	Group LCAG n=47 eyes 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.	Group AMG n=42 eyes 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.
Postoperative Conjunctival Inflammation Grade 0	21 eyes	14 eyes
Postoperative Conjunctival Inflammation Grade i	17 eyes	14 eyes
Postoperative Conjunctival Inflammation Grade ii	9 eyes	13 eyes
Postoperative Conjunctival Inflammation Grade iii	0 eyes	1 eyes

Adverse Events

Group LCAG

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Group AMG

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Group LCAG n=47 participants at risk 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.	Group AMG n=40 participants at risk 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.
Eye disorders Punctate epithelial keratitis	12.8% 6/47 • Number of events 6 • 1 year	12.5% 5/40 • Number of events 6 • 1 year
Eye disorders Local episcleral melting	4.3% 2/47 • Number of events 2 • 1 year	2.5% 1/40 • Number of events 1 • 1 year
Eye disorders Localized pannus at donor site	2.1% 1/47 • Number of events 1 • 1 year	0.00% 0/40 • 1 year
Eye disorders Delayed epithelializaiton of corneal defect	0.00% 0/47 • 1 year	2.5% 1/40 • Number of events 1 • 1 year

Additional Information

Dr. Shiyou Zhou

State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University

Phone: +86-020-87331540

Email: zhoushiy@mail.sysu.edu.cn

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: GT60