An interventional study of conjunctival autografting augmented with topical application of Mitomycin C and conjunctival autografting augmented with Ologen implantation in Recurrent Pterygium of Eye, sponsored by Menoufia University. Completed. Per ClinicalTrials.gov, last updated 2020-06-05.
Sponsored by Menoufia University · Not applicable, Interventional, and Treatment
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.
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
109 studies on the registry are indexed under Pterygium; 9 are open to participants now.
This study's enrollment of 63 is close to the median of 60 across 93 interventional studies indexed under Pterygium.
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recurrent nasal pterygium after one surgical session for removal of the primary one
Exclusion Criteria:
Group A included 32 eyes of 32 patients who underwent conjunctival autografting augmented with topical application of Mitomycin C (0.2 mg/mL).
Procedure: conjunctival autografting augmented with topical application of Mitomycin C · Procedure: conjunctival autografting augmented with Ologen implantation
Group B included 31 eyes of 31 who underwent conjunctival autografting augmented with Ologen implantation.
Procedure: conjunctival autografting augmented with topical application of Mitomycin C · Procedure: conjunctival autografting augmented with Ologen implantation
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.
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).
Time frame: "through study completion, an average of 1 year".
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)
Time frame: "through study completion, an average of 1 year".
No study locations are listed for this record.
This study is completed, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.
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