Recurrent Pterygium of EyeNCT04419038
Evaluation of Conjunctival Autografting With MMC Application Versus Ologen Implantation of Recurrent Pterygium
A study testing conjunctival autografting augmented with topical application of Mitomycin C and conjunctival autografting augmented with Ologen implantation in people with Recurrent Pterygium of Eye, run by Menoufia University.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Recurrent Pterygium of Eye
- What is being tested?
- conjunctival autografting augmented with topical application of Mitomycin C and conjunctival autografting augmented with Ologen implantation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- No sites listed yet
- Study dates
- 15 Jan 2016to 30 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- recurrent nasal pterygium after one surgical session for removal of the primary one
Who cannot join
- primary nasal pterygium,
- recurrent pterygium with more than one session for surgical removal
About this study
Official title: Evaluation of Conjunctival Autografting Augmented With Mitomycin-C Application Versus Ologen Implantation in Surgical Treatment of Recurrent Pterygium
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.
Read the 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
- Being tested
- conjunctival autografting augmented with topical application of Mitomycin C, conjunctival autografting augmented with Ologen implantation
- Medical subject headings
- Pterygium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conjunctival autografting augmented with topical application of Mitomycin CProcedure or surgery
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 implantationProcedure or surgery
Group B included 31 eyes of 31 who underwent conjunctival autografting augmented with Ologen implantation.
| Study group | Role | What they receive |
|---|---|---|
| conjunctival autografting with MMC | Active comparator | Group A included 32 eyes of 32 patients who underwent conjunctival autografting augmented with topical application of Mitomycin C (0.2 mg/mL). Receives: 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 B included 31 eyes of 31 who underwent conjunctival autografting augmented with Ologen implantation. Receives: Procedure: conjunctival autografting augmented with topical application of Mitomycin C; Procedure: conjunctival autografting augmented with Ologen implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: "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)
Measured: "through study completion, an average of 1 year".
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2020
- Study start15 Jan 2016
- Primary completion1 Dec 2019
- Study completion30 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Recurrent Pterygium of EyeStudies of the same condition, open and under way.
- More trials run by Menoufia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Menoufia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amin Faisal Ellakwa, Menoufia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04419038
- Sponsor's protocol ID
- 81046
- Status last verified
- Jun 2020
- First submitted
- 14 May 2020
- Last updated
- 5 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 33505715
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Conjunctival Autografting Augmented With Mitomycin-C Application Versus Ologen Implantation in Surgical Treatment of Recurrent Pterygium
- ClinicalTrials.gov ID
- NCT04419038
- Acronym / sponsor ID
- 81046
- Conditions
- Recurrent Pterygium of Eye
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Menoufia UniversityUniversity, hospital or other
- Study start
- 15 Jan 2016 (actual)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 30 Dec 2019 (actual)
- First posted
- 5 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| conjunctival autografting with MMC | Active comparator | Procedure: conjunctival autografting augmented with topical application of Mitomycin C, Procedure: conjunctival autografting augmented with Ologen implantationGroup 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 comparator | Procedure: conjunctival autografting augmented with topical application of Mitomycin C, Procedure: conjunctival autografting augmented with Ologen implantationGroup B included 31 eyes of 31 who underwent conjunctival autografting augmented with Ologen implantation. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- recurrent nasal pterygium after one surgical session for removal of the primary one
Key exclusion criteria (2 listed)
- primary nasal pterygium,
- recurrent pterygium with more than one session for surgical removal
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| conjunctival autografting augmented with topical application of Mitomycin CGroup A included 32 eyes of 32 patients who underwent conjunctival autografting augmented with topical application of Mitomycin C (0.2 mg/mL). | Procedure or surgery | conjunctival autografting augmented with Ologen implantation, conjunctival autografting with MMC |
| conjunctival autografting augmented with Ologen implantationGroup B included 31 eyes of 31 who underwent conjunctival autografting augmented with Ologen implantation. | Procedure or surgery | conjunctival autografting augmented with Ologen implantation, conjunctival autografting with MMC |
Primary outcome
32 eyes with Topical application of Mitomycin C in concentration of (0.2 mg/mL).
Time frame: "through study completion, an average of 1 year".
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.
Time frame: "through study completion, an average of 1 year".
In group B; Ologen was applied under the graft tissue once it is secured in place (half the vial is used for every patient)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2020.
- Derived from this study: PubMed 33505715Wagdy 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing conjunctival autografting augmented with topical application of Mitomycin C and conjunctival autografting augmented with Ologen implantation in people with Recurrent Pterygium of Eye, run by Menoufia University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
32 eyes with Topical application of Mitomycin C in concentration of (0.2 mg/mL). (time frame: "through study completion, an average of 1 year".). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04419038, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2020.