GlaucomaPhase 3MMCNCT06680245
Effect of Mitomycin-C on the Outcomes of Patients Receiving Ahmed Glaucoma Valve Implantation Surgery
A Phase 3 study testing Mitomycin c in people with Glaucoma, run by St. Joseph's Healthcare Hamilton.
Trial summary
The goal of this clinical trial is to determine if the intraoperative application of Mitomycin-C can enhance the outcomes of Ahmed Glaucoma Valve (AGV) implantation in treating refractory glaucoma. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Glaucoma
- What is being tested?
- Mitomycin c
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2024to 1 Dec 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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
- Diagnosis of primary open angle glaucoma (OAG); including ocular hypertension, pigmentary dispersion syndrome and pseudoexfoliation syndrome
- Participant must be over 18 years of age
- IOP > 16mmHg on at least two consecutive occasions separated by one month
- Two sighted eyes with visual acuity of 20/200 or better
- Informed consent from patient
Who cannot join
- Diagnosis of secondary OAG (aside from pigmentary and pseudoexfoliation glaucoma) or narrow angle glaucoma
- Previous incisional glaucoma surgery
- Incisional glaucoma surgery scheduled within 1 year of intervention
- Corneal disease affecting visualization of anterior chamber of the eye
- Treatment or plan to treat with topical or systemic steroids
- Previous laser treatments (selective laser trabeculoplasty or Argon laser trabeculoplasty)
- Other eye disorders or surgical procedures (ie retinal detachment) that may influence the results of glaucoma surgery.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
The goal of this clinical trial is to determine if the intraoperative application of Mitomycin-C can enhance the outcomes of Ahmed Glaucoma Valve (AGV) implantation in treating refractory glaucoma. This study is conducted among adult patients diagnosed with refractory glaucoma, a condition characterized by uncontrolled intraocular pressure despite the use of maximum tolerated medical therapy and previous surgical interventions. The main questions it aims to answer are:
Does intraoperative Mitomycin-C reduce postoperative intraocular pressure more effectively than surgery without it? Does Mitomycin-C reduce the occurrence of postoperative complications such as hypertensive phases?
Read more
Researchers will compare the experimental group receiving Mitomycin-C during AGV implantation to the control group undergoing AGV implantation without Mitomycin-C to see if the treatment leads to lower intraocular pressure and fewer surgical complications.
Participants will:
- Undergo baseline assessment including eye examination and measurement of intraocular pressure.
- Be randomly assigned to receive either the Mitomycin-C treatment or no intervention during their scheduled AGV implantation surgery.
- Attend follow-up visits at 1 week, 1 month, 3 months, 6 months, and 12 months post-surgery to assess intraocular pressure, visual acuity, and any postoperative complications.
- Conditions
- Glaucoma
- Being tested
- Mitomycin c
- Keywords
- Refractory Glaucoma, Intraocular Pressure, Ahmed Glaucoma Valve, Mitomycin-C, Glaucoma Surgery
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mitomycin cDrug
Patients needing Ahmed valve implants to control intraocular pressures will be eligible. Eligible patients who consent will be randomized to receive either mitomycin-C or no intervention during implant surgery. Screening visits occur one week before surgery to assess eligibility and take baseline measurements (visual acuity, IOP, anterior chamber reaction). On surgery day, patients register at SJHH King Campus and undergo randomization. IOP is measured using a tonopen in the OR. An experienced glaucoma specialist performs the surgery, injecting 0.2 mg/ml mitomycin-C into the sclera for the experimental group, while the control group receives no intervention. The area is irrigated with 40mL balanced salt solution before implant insertion. Post-operative care includes topical antibiotics and steroids for six weeks, with follow-ups at 1 and 2 weeks, and 1, 3, 6, and 12 months to monitor visual acuity, IOP, anterior chamber reaction, complications, and additional glaucoma medications.
| Study group | Role | What they receive |
|---|---|---|
| Mitomycin-C Treatment | Experimental | The intervention aims to assess the efficacy of Mitomycin-C in preventing postoperative hypertensive phases by inhibiting fibroblast proliferation around the surgical site. Patients in this arm will receive a 0.2 mg/mL Mitomycin-C injection into the sclera during Ahmed Glaucoma Valve implantation surgery. The total volume of the injection will be 1 mL, administered once intraoperatively. Receives: Drug: Mitomycin c |
| Control | No intervention | Patients in this arm will undergo the Ahmed Glaucoma Valve implantation surgery without the addition of Mitomycin-C. This group serves as a control to evaluate the effects of the Ahmed Valve alone in managing intraocular pressure in patients with refractory glaucoma. Postoperative care remains consistent with the experimental group, involving the same regimen of topical antibiotics and steroids. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Intraocular Pressure assessed using the Goldmann applanation tonometer
The percentage decrease in intraocular pressure (IOP) from baseline will be calculated and compared between the two groups from baseline to 1-year follow-up. It will be measured using the Goldmann applanation tonometer and performed at approximately the same time of the day to account for diurnal variation. Two measurements will be averaged if the difference is less or equal to 2mmHg. If the difference is greater than 2mmHg, then three measurements will be taken and the median will be recorded. The baseline IOP will be the average of three different IOP values taken at different times of the day on at least two separate days within a period of a month. In this study, the baseline IOP will be the average IOP of previous IOP measurement and the day of surgery.
Measured: Baseline to 1-year follow-up visit
Secondary outcomes (4)
Number of Glaucoma Medications assessed by reviewing of patient medication records
Changes in the number of glaucoma medications need per patient in each group will be compared using observations and by reviewing patient medication records from baseline to 1-year follow-up. This outcome will assess whether the intervention affects the number of prescribed glaucoma medications for the patients.
Measured: Baseline to 1-year follow-up visit
Visual Acuity assessed using the Snellen chart.
Changes in visual acuity from baseline to 1-year follow-up will be measured using the Snellen chart. This outcome will assess whether the intervention affects the overall visual function of the patients.
Measured: Baseline to 1-year follow-up visit
Anterior Chamber Inflammation assessed using the Slit-lamp examination
The anterior chamber inflammation at every post-operative visit will be compared to assess any complications during the surgery. This will be measured using the slit-lamp examination.
Measured: Baseline to 1-year follow-up visit
Progression to Surgical Therapy measured using clinical evaluation and surgical records.
The progression to surgical therapy in each group will be compared from baseline to 1-year follow-up.
Measured: Baseline to 1-year follow-up visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2024
- Study start1 Dec 2024 (estimated)
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for GlaucomaStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study design is a parallel-armed clinical superiority randomized trial. The study participants will be blinded to the use of the mitomycin-c with the Ahmed valve implant. Participants will be randomly allocated to either the experimental group using mitomycin-c injections or the control group receiving no intervention. The trial will be conducted at the Hamilton Regional Eye Clinic at St. Joseph's Healthcare Hamilton to maintain standardization of care and follow-up.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Joseph's Healthcare Hamilton
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Enitan Sogbesan, St. Joseph's Healthcare Hamilton
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06680245
- Sponsor's protocol ID
- 16370
- Acronym
- MMC
- Status last verified
- Nov 2024
- First submitted
- 27 May 2024
- Last updated
- 8 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Weinreb RN, Aung T, Medeiros FA. The pathophysiology and treatment of glaucoma: a review. JAMA. 2014 May 14;311(18):1901-11. doi: 10.1001/jama.2014.3192.
PubMed 24825645Quigley HA. Glaucoma. Lancet. 2011 Apr 16;377(9774):1367-77. doi: 10.1016/S0140-6736(10)61423-7. Epub 2011 Mar 30.
PubMed 21453963Margolis KL, Rich EC. Open-angle glaucoma. Prim Care. 1989 Mar;16(1):197-209.
PubMed 2649902Sharts-Hopko NC, Glynn-Milley C. Primary open-angle glaucoma. Am J Nurs. 2009 Feb;109(2):40-7; quiz 48. doi: 10.1097/01.NAJ.0000345434.37734.ee.
PubMed 19299999Alasbali T, Alghamdi AA, Khandekar R. Outcomes of Ahmed valve surgery for refractory glaucoma in Dhahran, Saudi Arabia. Int J Ophthalmol. 2015 Jun 18;8(3):560-4. doi: 10.3980/j.issn.2222-3959.2015.03.22. eCollection 2015.
PubMed 26086008Heijl A, Leske MC, Bengtsson B, Hyman L, Bengtsson B, Hussein M; Early Manifest Glaucoma Trial Group. Reduction of intraocular pressure and glaucoma progression: results from the Early Manifest Glaucoma Trial. Arch Ophthalmol. 2002 Oct;120(10):1268-79. doi: 10.1001/archopht.120.10.1268.
PubMed 12365904Riva I, Roberti G, Oddone F, Konstas AG, Quaranta L. Ahmed glaucoma valve implant: surgical technique and complications. Clin Ophthalmol. 2017 Feb 17;11:357-367. doi: 10.2147/OPTH.S104220. eCollection 2017.
PubMed 28255226Kurnaz E, Kubaloglu A, Yilmaz Y, Koytak A, Ozertrk Y. The effect of adjunctive mitomycin C in Ahmed glaucoma valve implantation. Eur J Ophthalmol. 2005 Jan - Feb 2005;15(1):27-31. doi: 10.5301/EJO.2008.210.
PubMed 28221428Luzu J, Baudouin C, Hamard P. The role of Ahmed glaucoma valve in the management of refractory glaucoma: Long-term outcomes and complications. Eur J Ophthalmol. 2021 Sep;31(5):2383-2389. doi: 10.1177/1120672120968733. Epub 2020 Nov 25.
PubMed 33238768Amoozgar B, Lin SC, Han Y, Kuo J. A role for antimetabolites in glaucoma tube surgery: current evidence and future directions. Curr Opin Ophthalmol. 2016 Mar;27(2):164-9. doi: 10.1097/ICU.0000000000000244.
PubMed 26720778Cui QN, Hsia YC, Lin SC, Stamper RL, Rose-Nussbaumer J, Mehta N, Porco TC, Naseri A, Han Y. Effect of mitomycin c and 5-flurouracil adjuvant therapy on the outcomes of Ahmed glaucoma valve implantation. Clin Exp Ophthalmol. 2017 Mar;45(2):128-134. doi: 10.1111/ceo.12811. Epub 2016 Sep 1.
PubMed 27490793Costa VP, Azuara-Blanco A, Netland PA, Lesk MR, Arcieri ES. Efficacy and safety of adjunctive mitomycin C during Ahmed Glaucoma Valve implantation: a prospective randomized clinical trial. Ophthalmology. 2004 Jun;111(6):1071-6. doi: 10.1016/j.ophtha.2003.09.037.
PubMed 15177955Kook MS, Yoon J, Kim J, Lee MS. Clinical results of Ahmed glaucoma valve implantation in refractory glaucoma with adjunctive mitomycin C. Ophthalmic Surg Lasers. 2000 Mar-Apr;31(2):100-6.
PubMed 10743919Tien M., Yip L., Wong E.P.Y., Yong V., Wong H.T. & Lim B.A. (2013). The effect of adjuvant mitomycin C in ahmed glaucoma valve surgery for refractory glaucoma. Investigative Ophthalmology and Visual Science, 54(15), no pagination. Retrieved from http://ovidsp.ovid.com/ovidweb.cgi?T=JS&PAGE=reference&D=emed14&NEWS=N&AN=628682336.
Kurnaz E, Kubaloglu A, Yilmaz Y, Koytak A, Ozerturk Y. The effect of adjunctive Mitomycin C in Ahmed glaucoma valve implantation. Eur J Ophthalmol. 2005 Jan-Feb;15(1):27-31.
PubMed 15751236
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Mitomycin-C on the Outcomes of Patients Receiving Ahmed Glaucoma Valve Implantation Surgery
- ClinicalTrials.gov ID
- NCT06680245
- Acronym / sponsor ID
- MMC / 16370
- Conditions
- Glaucoma
- Keywords
- Refractory Glaucoma, Intraocular Pressure, Ahmed Glaucoma Valve, Mitomycin-C, Glaucoma Surgery
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- St. Joseph's Healthcare HamiltonUniversity, hospital or other
- Study start
- 1 Dec 2024 (estimated)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 8 Nov 2024 (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.
The goal of this clinical trial is to determine if the intraoperative application of Mitomycin-C can enhance the outcomes of Ahmed Glaucoma Valve (AGV) implantation in treating refractory glaucoma. This study is conducted among adult patients diagnosed with refractory glaucoma, a condition characterized by uncontrolled intraocular pressure despite the use of maximum tolerated medical therapy and previous surgical interventions. The main questions it aims to answer are:
Does intraoperative Mitomycin-C reduce postoperative intraocular pressure more effectively than surgery without it? Does Mitomycin-C reduce the occurrence of postoperative complications such as hypertensive phases?
Researchers will compare the experimental group receiving Mitomycin-C during AGV implantation to the control group undergoing AGV implantation without Mitomycin-C to see if the treatment leads to lower intraocular pressure and fewer surgical complications.
Participants will:
- Undergo baseline assessment including eye examination and measurement of intraocular pressure.
- Be randomly assigned to receive either the Mitomycin-C treatment or no intervention during their scheduled AGV implantation surgery.
- Attend follow-up visits at 1 week, 1 month, 3 months, 6 months, and 12 months post-surgery to assess intraocular pressure, visual acuity, and any postoperative complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- The study design is a parallel-armed clinical superiority randomized trial. The study participants will be blinded to the use of the mitomycin-c with the Ahmed valve implant. Participants will be randomly allocated to either the experimental group using mitomycin-c injections or the control group receiving no intervention. The trial will be conducted at the Hamilton Regional Eye Clinic at St. Joseph's Healthcare Hamilton to maintain standardization of care and follow-up.
| Arm | Type | Receives |
|---|---|---|
| Mitomycin-C Treatment | Experimental | Drug: Mitomycin cThe intervention aims to assess the efficacy of Mitomycin-C in preventing postoperative hypertensive phases by inhibiting fibroblast proliferation around the surgical site. Patients in this arm will receive a 0.2 mg/mL Mitomycin-C injection into the sclera during Ahmed Glaucoma Valve implantation surgery. The total volume of the injection will be 1 mL, administered once intraoperatively. |
| Control | No intervention | –Patients in this arm will undergo the Ahmed Glaucoma Valve implantation surgery without the addition of Mitomycin-C. This group serves as a control to evaluate the effects of the Ahmed Valve alone in managing intraocular pressure in patients with refractory glaucoma. Postoperative care remains consistent with the experimental group, involving the same regimen of topical antibiotics and steroids. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of primary open angle glaucoma (OAG); including ocular hypertension, pigmentary dispersion syndrome and pseudoexfoliation syndrome
- Participant must be over 18 years of age
- IOP > 16mmHg on at least two consecutive occasions separated by one month
- Two sighted eyes with visual acuity of 20/200 or better
- Informed consent from patient
Key exclusion criteria (7 listed)
- Diagnosis of secondary OAG (aside from pigmentary and pseudoexfoliation glaucoma) or narrow angle glaucoma
- Previous incisional glaucoma surgery
- Incisional glaucoma surgery scheduled within 1 year of intervention
- Corneal disease affecting visualization of anterior chamber of the eye
- Treatment or plan to treat with topical or systemic steroids
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 cPatients needing Ahmed valve implants to control intraocular pressures will be eligible. Eligible patients who consent will be randomized to receive either mitomycin-C or no intervention during implant surgery. Screening visits occur one week before surgery to assess eligibility and take baseline measurements (visual acuity, IOP, anterior chamber reaction). On surgery day, patients register at SJHH King Campus and undergo randomization. IOP is measured using a tonopen in the OR. An experienced glaucoma specialist performs the surgery, injecting 0.2 mg/ml mitomycin-C into the sclera for the experimental group, while the control group receives no intervention. The area is irrigated with 40mL balanced salt solution before implant insertion. Post-operative care includes topical antibiotics and steroids for six weeks, with follow-ups at 1 and 2 weeks, and 1, 3, 6, and 12 months to monitor visual acuity, IOP, anterior chamber reaction, complications, and additional glaucoma medications. | Drug | Mitomycin-C Treatment |
Primary outcome
Change in Intraocular Pressure assessed using the Goldmann applanation tonometer
Time frame: Baseline to 1-year follow-up visit
The percentage decrease in intraocular pressure (IOP) from baseline will be calculated and compared between the two groups from baseline to 1-year follow-up. It will be measured using the Goldmann applanation tonometer and performed at approximately the same time of the day to account for diurnal variation. Two measurements will be averaged if the difference is less or equal to 2mmHg. If the difference is greater than 2mmHg, then three measurements will be taken and the median will be recorded. The baseline IOP will be the average of three different IOP values taken at different times of the day on at least two separate days within a period of a month. In this study, the baseline IOP will be the average IOP of previous IOP measurement and the day of surgery.
4 secondary outcomes
Number of Glaucoma Medications assessed by reviewing of patient medication records
Time frame: Baseline to 1-year follow-up visit
Visual Acuity assessed using the Snellen chart.
Time frame: Baseline to 1-year follow-up visit
Anterior Chamber Inflammation assessed using the Slit-lamp examination
Time frame: Baseline to 1-year follow-up visit
Progression to Surgical Therapy measured using clinical evaluation and surgical records.
Time frame: Baseline to 1-year follow-up visit
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2024.
- Background: PubMed 24825645Weinreb RN, Aung T, Medeiros FA. The pathophysiology and treatment of glaucoma: a review. JAMA. 2014 May 14;311(18):1901-11. doi: 10.1001/jama.2014.3192.
- Background: PubMed 21453963Quigley HA. Glaucoma. Lancet. 2011 Apr 16;377(9774):1367-77. doi: 10.1016/S0140-6736(10)61423-7. Epub 2011 Mar 30.
- Background: PubMed 2649902Margolis KL, Rich EC. Open-angle glaucoma. Prim Care. 1989 Mar;16(1):197-209.
- Background: PubMed 19299999Sharts-Hopko NC, Glynn-Milley C. Primary open-angle glaucoma. Am J Nurs. 2009 Feb;109(2):40-7; quiz 48. doi: 10.1097/01.NAJ.0000345434.37734.ee.
- Background: PubMed 26086008Alasbali T, Alghamdi AA, Khandekar R. Outcomes of Ahmed valve surgery for refractory glaucoma in Dhahran, Saudi Arabia. Int J Ophthalmol. 2015 Jun 18;8(3):560-4. doi: 10.3980/j.issn.2222-3959.2015.03.22. eCollection 2015.
- Background: PubMed 12365904Heijl A, Leske MC, Bengtsson B, Hyman L, Bengtsson B, Hussein M; Early Manifest Glaucoma Trial Group. Reduction of intraocular pressure and glaucoma progression: results from the Early Manifest Glaucoma Trial. Arch Ophthalmol. 2002 Oct;120(10):1268-79. doi: 10.1001/archopht.120.10.1268.
- Background: PubMed 28255226Riva I, Roberti G, Oddone F, Konstas AG, Quaranta L. Ahmed glaucoma valve implant: surgical technique and complications. Clin Ophthalmol. 2017 Feb 17;11:357-367. doi: 10.2147/OPTH.S104220. eCollection 2017.
- Background: PubMed 28221428Kurnaz E, Kubaloglu A, Yilmaz Y, Koytak A, Ozertrk Y. The effect of adjunctive mitomycin C in Ahmed glaucoma valve implantation. Eur J Ophthalmol. 2005 Jan - Feb 2005;15(1):27-31. doi: 10.5301/EJO.2008.210.
- Background: PubMed 33238768Luzu J, Baudouin C, Hamard P. The role of Ahmed glaucoma valve in the management of refractory glaucoma: Long-term outcomes and complications. Eur J Ophthalmol. 2021 Sep;31(5):2383-2389. doi: 10.1177/1120672120968733. Epub 2020 Nov 25.
- Background: PubMed 26720778Amoozgar B, Lin SC, Han Y, Kuo J. A role for antimetabolites in glaucoma tube surgery: current evidence and future directions. Curr Opin Ophthalmol. 2016 Mar;27(2):164-9. doi: 10.1097/ICU.0000000000000244.
- Background: PubMed 27490793Cui QN, Hsia YC, Lin SC, Stamper RL, Rose-Nussbaumer J, Mehta N, Porco TC, Naseri A, Han Y. Effect of mitomycin c and 5-flurouracil adjuvant therapy on the outcomes of Ahmed glaucoma valve implantation. Clin Exp Ophthalmol. 2017 Mar;45(2):128-134. doi: 10.1111/ceo.12811. Epub 2016 Sep 1.
- Background: PubMed 15177955Costa VP, Azuara-Blanco A, Netland PA, Lesk MR, Arcieri ES. Efficacy and safety of adjunctive mitomycin C during Ahmed Glaucoma Valve implantation: a prospective randomized clinical trial. Ophthalmology. 2004 Jun;111(6):1071-6. doi: 10.1016/j.ophtha.2003.09.037.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Mitomycin c in people with Glaucoma, run by St. Joseph's Healthcare Hamilton.
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 5 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: opening soon, as of the sponsor's last update on 8 Nov 2024. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sharan Bains (905-522-1155 ext. 38505, bainss@mcmaster.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Intraocular Pressure assessed using the Goldmann applanation tonometer (time frame: Baseline to 1-year follow-up visit). 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 NCT06680245, which also lists 18 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 8 Nov 2024.