Evaluation of Conjunctival Autografting With MMC Application Versus Ologen Implantation of Recurrent Pterygium
1 other identifier
interventional
63
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2016
Longer than P75 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 15, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2019
CompletedFirst Submitted
Initial submission to the registry
May 14, 2020
CompletedFirst Posted
Study publicly available on registry
June 5, 2020
CompletedJune 5, 2020
June 1, 2020
3.9 years
May 14, 2020
June 2, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
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).
"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)
"through study completion, an average of 1 year".
Study Arms (2)
conjunctival autografting with MMC
ACTIVE COMPARATORGroup 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
ACTIVE COMPARATORGroup B included 31 eyes of 31 who underwent conjunctival autografting augmented with Ologen implantation.
Interventions
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.
Eligibility Criteria
You may qualify if:
- recurrent nasal pterygium after one surgical session for removal of the primary one
You may not qualify if:
- primary nasal pterygium,
- recurrent pterygium with more than one session for surgical removal
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 33505715DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- clinical professor
Study Record Dates
First Submitted
May 14, 2020
First Posted
June 5, 2020
Study Start
January 15, 2016
Primary Completion
December 1, 2019
Study Completion
December 30, 2019
Last Updated
June 5, 2020
Record last verified: 2020-06