Evaluation of Conjunctival Autografting With MMC Application Versus Ologen Implantation of Recurrent Pterygium

M

Menoufia University

Status

Completed

Conditions

Recurrent Pterygium of Eye

Treatments

Procedure: conjunctival autografting augmented with Ologen implantation
Procedure: conjunctival autografting augmented with topical application of Mitomycin C

Study type

Interventional

Funder types

Other

Identifiers

NCT04419038
81046

Details and patient eligibility

About

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.

Full 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

Enrollment

63 patients

Sex

All

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

63 participants in 2 patient groups

conjunctival autografting with MMC
Active Comparator group
Description:
Group A included 32 eyes of 32 patients who underwent conjunctival autografting augmented with topical application of Mitomycin C (0.2 mg/mL).
Treatment:
Procedure: conjunctival autografting augmented with topical application of Mitomycin C
Procedure: conjunctival autografting augmented with Ologen implantation
conjunctival autografting augmented with Ologen implantation
Active Comparator group
Description:
Group B included 31 eyes of 31 who underwent conjunctival autografting augmented with Ologen implantation.
Treatment:
Procedure: conjunctival autografting augmented with topical application of Mitomycin C
Procedure: conjunctival autografting augmented with Ologen implantation

Trial contacts and locations

0

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems