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

NCT ID: NCT04419038

Last Updated: 2020-06-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 63 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-15
• Study Completion Date: 2019-12-30

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

Conditions

Recurrent Pterygium of Eye

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

conjunctival autografting with MMC

Group A included 32 eyes of 32 patients who underwent conjunctival autografting augmented with topical application of Mitomycin C (0.2 mg/mL).

Group Type: ACTIVE_COMPARATOR

conjunctival autografting augmented with topical application of Mitomycin C

Intervention Type: PROCEDURE

Group A included 32 eyes of 32 patients who underwent conjunctival autografting augmented with topical application of Mitomycin C (0.2 mg/mL).

conjunctival autografting augmented with Ologen implantation

Intervention Type: PROCEDURE

Group B included 31 eyes of 31 who underwent conjunctival autografting augmented with Ologen implantation.

conjunctival autografting augmented with Ologen implantation

Group B included 31 eyes of 31 who underwent conjunctival autografting augmented with Ologen implantation.

Group Type: ACTIVE_COMPARATOR

conjunctival autografting augmented with topical application of Mitomycin C

Intervention Type: PROCEDURE

Group A included 32 eyes of 32 patients who underwent conjunctival autografting augmented with topical application of Mitomycin C (0.2 mg/mL).

conjunctival autografting augmented with Ologen implantation

Intervention Type: PROCEDURE

Group B included 31 eyes of 31 who underwent conjunctival autografting augmented with Ologen implantation.

Interventions

conjunctival autografting augmented with topical application of Mitomycin C

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

conjunctival autografting augmented with Ologen implantation

Group B included 31 eyes of 31 who underwent conjunctival autografting augmented with Ologen implantation.

Intervention Type: PROCEDURE

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Menoufia University

OTHER

Sponsor Role: lead

Responsible Party

Amin Faisal Ellakwa

clinical professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

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.

Reference Type: DERIVED

PMID: 33505715 (View on PubMed)

Other Identifiers

81046

Identifier Type: -

Identifier Source: org_study_id