Evaluation of Conjunctival Autografting With MMC Application Versus Ologen Implantation of Recurrent Pterygium
Primary Purpose
Recurrent Pterygium of Eye
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
conjunctival autografting augmented with topical application of Mitomycin C
conjunctival autografting augmented with Ologen implantation
Sponsored by
About this trial
This is an interventional treatment trial for Recurrent Pterygium of Eye
Eligibility Criteria
Inclusion Criteria:
recurrent nasal pterygium after one surgical session for removal of the primary one
Exclusion Criteria:
- primary nasal pterygium,
- recurrent pterygium with more than one session for surgical removal
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
conjunctival autografting with MMC
conjunctival autografting augmented with Ologen implantation
Arm Description
Group A included 32 eyes of 32 patients who underwent conjunctival autografting augmented with topical application of Mitomycin C (0.2 mg/mL).
Group B included 31 eyes of 31 who underwent conjunctival autografting augmented with Ologen implantation.
Outcomes
Primary Outcome Measures
32 eyes with Topical application of Mitomycin C in concentration of (0.2 mg/mL).
As for group A, 0.2 mg/mL MMC was prepared by reconstituting 2 mg vial of Mitomycin with 10 mL sterile water for injection. When using Mitomycin 10 mg vial, the same concentration was achieved by reconstituting the 10 mg vial 10 mL sterile water for injection. Then 1 ml of the prepared solution was diluted with 4 ml of saline to achieve 0.2 mg/mL (0.02% solution).
31 eyes with ologen implantation(6 mm in diameter and 2 mm thick.) was used for each patient.
In group B; Ologen was applied under the graft tissue once it is secured in place (half the vial is used for every patient)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04419038
Brief Title
Evaluation of Conjunctival Autografting With MMC Application Versus Ologen Implantation of Recurrent Pterygium
Official Title
Evaluation of Conjunctival Autografting Augmented With Mitomycin-C Application Versus Ologen Implantation in Surgical Treatment of Recurrent Pterygium
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
January 15, 2016 (Actual)
Primary Completion Date
December 1, 2019 (Actual)
Study Completion Date
December 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Menoufia University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Ologen implantation with conjunctival autografting shows promising results in surgical management of recurrent pterygium comparable to MMC application with conjunctival autografting with mild non vision threatening postoperative complications.
Detailed Description
Patients were randomly enrolled into two groups. Group A included 32 eyes of 32 patients who underwent conjunctival autografting augmented with topical application of Mitomycin C (0.2 mg/mL). Group B included 31 eyes of 31 who underwent conjunctival autografting augmented with Ologen implantation.
All patients had a recurrent nasal pterygium after one surgical session for removal of the primary one. Any patient with primary nasal pterygium, or patients with recurrent pterygium who had more than one session for surgical removal were excluded. As well, patients with cicatrizing conjunctival disease or previous conjunctival surgery were excluded from the study.
A comprehensive ophthalmic examination, including best-corrected visual acuity testing, slit-lamp examination, Goldmann applanation tonometry, fundus examination, and examination of ocular motility, was carried out for all patients. According to their corneal extent, pterygia were classified into 3 grades:
Grade 1: Fibrovascular proliferations extend up to one quarter of the corneal diameter.
Grade 2: Fibrovascular proliferations extend up to the center of the cornea. Grade 3: Fibrovascular proliferations extend beyond the visual axis.
Consents were taken from all patients and research was approved by the institutional review board. All measures were in accordance with the tenets of the Declaration of Helsinki.
As for group A, 0.2 mg/mL MMC was prepared by reconstituting 2 mg vial of Mitomycin with 10 mL sterile water for injection. When using Mitomycin 10 mg vial, the same concentration was achieved by reconstituting the 10 mg vial 10 mL sterile water for injection. Then 1 ml of the prepared solution was diluted with 4 ml of saline to achieve 0.2 mg/mL (0.02% solution). This solution is stable for 2 weeks under refrigeration, and 24 hours at room temperature (59° to 86°F).
As for group B, 1×2 or 2×2 square millimeter porous collagen matrix was used for each patient
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Pterygium of Eye
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
63 (Actual)
8. Arms, Groups, and Interventions
Arm Title
conjunctival autografting with MMC
Arm Type
Active Comparator
Arm Description
Group A included 32 eyes of 32 patients who underwent conjunctival autografting augmented with topical application of Mitomycin C (0.2 mg/mL).
Arm Title
conjunctival autografting augmented with Ologen implantation
Arm Type
Active Comparator
Arm Description
Group B included 31 eyes of 31 who underwent conjunctival autografting augmented with Ologen implantation.
Intervention Type
Procedure
Intervention Name(s)
conjunctival autografting augmented with topical application of Mitomycin C
Intervention Description
Group A included 32 eyes of 32 patients who underwent conjunctival autografting augmented with topical application of Mitomycin C (0.2 mg/mL).
Intervention Type
Procedure
Intervention Name(s)
conjunctival autografting augmented with Ologen implantation
Intervention Description
Group B included 31 eyes of 31 who underwent conjunctival autografting augmented with Ologen implantation.
Primary Outcome Measure Information:
Title
32 eyes with Topical application of Mitomycin C in concentration of (0.2 mg/mL).
Description
As for group A, 0.2 mg/mL MMC was prepared by reconstituting 2 mg vial of Mitomycin with 10 mL sterile water for injection. When using Mitomycin 10 mg vial, the same concentration was achieved by reconstituting the 10 mg vial 10 mL sterile water for injection. Then 1 ml of the prepared solution was diluted with 4 ml of saline to achieve 0.2 mg/mL (0.02% solution).
Time Frame
"through study completion, an average of 1 year".
Title
31 eyes with ologen implantation(6 mm in diameter and 2 mm thick.) was used for each patient.
Description
In group B; Ologen was applied under the graft tissue once it is secured in place (half the vial is used for every patient)
Time Frame
"through study completion, an average of 1 year".
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
recurrent nasal pterygium after one surgical session for removal of the primary one
Exclusion Criteria:
primary nasal pterygium,
recurrent pterygium with more than one session for surgical removal
12. IPD Sharing Statement
Citations:
PubMed Identifier
33505715
Citation
Wagdy FM, Farahat HG, Ellakwa AF, Mandour SS. Evaluation of Conjunctival Autografting Augmented with Mitomycin C Application versus Ologen Implantation in the Surgical Treatment of Recurrent Pterygium. J Ophthalmol. 2021 Jan 12;2021:8820926. doi: 10.1155/2021/8820926. eCollection 2021.
Results Reference
derived
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Evaluation of Conjunctival Autografting With MMC Application Versus Ologen Implantation of Recurrent Pterygium
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