PterygiumPhase 4PHB-MMC1NCT02641132
Pterygium Head Body MMC1: Two Different Surgical Procedures and Their Effect on Endothelial Cell Count.
A Phase 4 study testing Mitomycin C 0.02% and Pterygium surgery in people with Pterygium, run by Meir Medical Center at 2 sites in Israel.
Trial summary
To evaluate changes in endothelial cell count after pterygium surgery with mitomycin C (MMC) 0.02% Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pterygium
- What is being tested?
- Mitomycin C 0.02% and Pterygium surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 2 sitesIsrael
- Study dates
- Sep 2015to Dec 2016
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Males/females >18 Years old
- Pterygium with indication to operate
- Subjects that are able to sign an informed consent
Who cannot join
- Recurrent Pterygium/suspected tumor lesion
- Patients with endothelial cell diseases
- Patients after anterior segment surgery
- Patients with low compliance
- Patients without judgment ability
- Pregnancy
- Patients participated in another survey
Trial locations and contacts
2 sites in 1 country.
Israel2 sites
Meir medical centre
Kfar Saba
Sackler school of medicine
Tel Aviv, Israel
About this study
Official title: The Comparison of Endothelial Cell Count in Pterygium Surgery Relating to the Timing of MMC Application.
To evaluate changes in endothelial cell count after pterygium surgery with mitomycin C (MMC) 0.02%
Read the detailed description
To evaluate the change in endothelial cell count in patients after pterygium surgery with mitomycin C (MMC) 0.02% for 2 minutes in 2 groups.
- The control group: application of MMC after excision of the body of the pterygium without the head
- The study group: application of MMC after excision of the body and the head of the pterygium
- Conditions
- Pterygium
- Being tested
- Mitomycin C 0.02%, Pterygium surgery
- Medical subject headings
- Pterygium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mitomycin C 0.02%Drug
Pterygium excision with application of mitomycin C
Pterygium surgeryProcedure or surgery
Two different procedures- excision of the head and the body and excision of the head only
| Study group | Role | What they receive |
|---|---|---|
| Pterygium surgery: Head and body. | Experimental | Application of Mitomycin C 0.02% after excision of the body and the head of the pterygium. Receives: Drug: Mitomycin C 0.02%; Procedure: Pterygium surgery |
| Pterygium surgery: Body. | Active comparator | Application of Mitomycin C 0.02% after excision of the body only of the pterygium. Receives: Drug: Mitomycin C 0.02%; Procedure: Pterygium surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endothelial cell count
Measured: 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2015 (estimated)
- Study startSep 2015
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for PterygiumStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, segev fani, Meir Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02641132
- Sponsor's protocol ID
- 0091-13-MMC
- Acronym
- PHB-MMC1
- Status last verified
- Aug 2015
- First submitted
- 23 Dec 2015
- Last updated
- 29 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Avisar R, Avisar I, Bahar I, Weinberger D. Effect of mitomycin C in pterygium surgery on corneal endothelium. Cornea. 2008 Jun;27(5):559-61. doi: 10.1097/ICO.0b013e318165b158.
PubMed 18520505Bahar I, Kaiserman I, Lange AP, Slomovic A, Levinger E, Sansanayudh W, Slomovic AR. The effect of mitomycin C on corneal endothelium in pterygium surgery. Am J Ophthalmol. 2009 Mar;147(3):447-452.e1. doi: 10.1016/j.ajo.2008.08.035. Epub 2008 Nov 7.
PubMed 18992871Avisar R, Apel I, Avisar I, Weinberger D. Endothelial cell loss during pterygium surgery: importance of timing of mitomycin C application. Cornea. 2009 Sep;28(8):879-81. doi: 10.1097/ICO.0b013e3181a3900c.
PubMed 19654528Kheirkhah A, Izadi A, Kiarudi MY, Nazari R, Hashemian H, Behrouz MJ. Effects of mitomycin C on corneal endothelial cell counts in pterygium surgery: role of application location. Am J Ophthalmol. 2011 Mar;151(3):488-93. doi: 10.1016/j.ajo.2010.09.014. Epub 2011 Jan 13.
PubMed 21236405
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comparison of Endothelial Cell Count in Pterygium Surgery Relating to the Timing of MMC Application.
- ClinicalTrials.gov ID
- NCT02641132
- Acronym / sponsor ID
- PHB-MMC1 / 0091-13-MMC
- Conditions
- Pterygium
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 29 Dec 2015 (estimated)
- 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.
To evaluate changes in endothelial cell count after pterygium surgery with mitomycin C (MMC) 0.02%
Detailed description
To evaluate the change in endothelial cell count in patients after pterygium surgery with mitomycin C (MMC) 0.02% for 2 minutes in 2 groups.
- The control group: application of MMC after excision of the body of the pterygium without the head
- The study group: application of MMC after excision of the body and the head of the pterygium
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pterygium surgery: Head and body. | Experimental | Drug: Mitomycin C 0.02%, Procedure: Pterygium surgeryApplication of Mitomycin C 0.02% after excision of the body and the head of the pterygium. |
| Pterygium surgery: Body. | Active comparator | Drug: Mitomycin C 0.02%, Procedure: Pterygium surgeryApplication of Mitomycin C 0.02% after excision of the body only of the pterygium. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Males/females >18 Years old
- Pterygium with indication to operate
- Subjects that are able to sign an informed consent
Key exclusion criteria (7 listed)
- Recurrent Pterygium/suspected tumor lesion
- Patients with endothelial cell diseases
- Patients after anterior segment surgery
- Patients with low compliance
- Patients without judgment ability
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 |
|---|---|---|
| Mitomycin C 0.02%Pterygium excision with application of mitomycin C | Drug | Pterygium surgery: Body., Pterygium surgery: Head and body. |
| Pterygium surgeryTwo different procedures- excision of the head and the body and excision of the head only | Procedure or surgery | Pterygium surgery: Body., Pterygium surgery: Head and body. |
Primary outcome
Endothelial cell count
Time frame: 3 months after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2015.
- Background: PubMed 18520505Avisar R, Avisar I, Bahar I, Weinberger D. Effect of mitomycin C in pterygium surgery on corneal endothelium. Cornea. 2008 Jun;27(5):559-61. doi: 10.1097/ICO.0b013e318165b158.
- Background: PubMed 18992871Bahar I, Kaiserman I, Lange AP, Slomovic A, Levinger E, Sansanayudh W, Slomovic AR. The effect of mitomycin C on corneal endothelium in pterygium surgery. Am J Ophthalmol. 2009 Mar;147(3):447-452.e1. doi: 10.1016/j.ajo.2008.08.035. Epub 2008 Nov 7.
- Background: PubMed 19654528Avisar R, Apel I, Avisar I, Weinberger D. Endothelial cell loss during pterygium surgery: importance of timing of mitomycin C application. Cornea. 2009 Sep;28(8):879-81. doi: 10.1097/ICO.0b013e3181a3900c.
- Background: PubMed 21236405Kheirkhah A, Izadi A, Kiarudi MY, Nazari R, Hashemian H, Behrouz MJ. Effects of mitomycin C on corneal endothelial cell counts in pterygium surgery: role of application location. Am J Ophthalmol. 2011 Mar;151(3):488-93. doi: 10.1016/j.ajo.2010.09.014. Epub 2011 Jan 13.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Mitomycin C 0.02% and Pterygium surgery in people with Pterygium, run by Meir Medical Center at 2 sites in Israel.
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 3 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 29 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fani Segev, MD (+792526995044, fsegev@netvision.net.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endothelial cell count (time frame: 3 months after surgery). 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 NCT02641132, which also lists 4 linked publications.
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 29 Dec 2015.