Glaucoma, Open-AngleECONCT06201455
Evaluation of Phacogoniotomy in Medically-controlled POAG
A study testing PEI+GT and PEI+MED in people with Glaucoma, Open-Angle and Cataract Complicated, run by Sun Yat-sen University at 1 site in China.
Trial summary
The goal of this multicenter non-inferiority randomized controlled trial is to compare the efficacy of phacoemulsification with intraocular lens implantation (PEI) combined with goniotomy (GT) and PEI combined with medical therapy (MED) in the treatment of medically-controlled primary open-angle glaucoma (POAG) with… Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Glaucoma, Open-Angle, Cataract Complicated, Goniotomy
- What is being tested?
- PEI+GT and PEI+MED
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 28 Sep 2023to 31 Dec 2029
- Phase
- Interventional
- 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 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 40 ≤ Age ≤ 85 years, gender unrestricted.
- Diagnosed with POAG.
- Controlled IOP under 1 to 4 topical hypotensive medications, IOP ≤ 24 mmHg
- Mean deviation (MD) for perimetry ≥ -16dB.
- Presence of clinically significant cataract and best-corrected visual acuity measured using the ETDRS chart ≤ 0.63.
- Voluntary participation of the patient in this study, signing an informed consent form, and agreeing to follow-up visits according to the study protocol.
Who cannot join
- Any history of intraocular surgery or ocular trauma.
- Presence of other types of glaucoma, including primary angle-closure glaucoma and various forms of secondary glaucoma (e.g. secondary angle-closure, pigmentary, steroid-induced, angle-recession, neovascular, inflammatory, and pseudoexfoliation syndrome).
- Presence of severe ocular diseases of various types that affect the acquisition of ocular parameters or interfere with perimetry.
- Axial length > 28 mm.
- Monophthalmia (best-corrected visual acuity of the non-study eye < 0.01).
- Coexistence of severe systemic diseases affecting the entire body.
- Pregnant or lactating women.
- If both eyes of a patient meet the criteria, the eye with worse visual acuity will be selected for inclusion.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Zhongshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, Guangdong, 510060
Xiulan Zhang, MD, PhD, +86 13059106657, zhangxl2@mail.sysu.edu.cn
Yunhe Song, MD, PhD, +86 13059106657, songyh33@mail.sysu.edu.cn
About this study
Official title: Efficacy of Phacogoniotomy in Medically-controlled Primary Open-angle Glaucoma With Cataract a Multicenter Non-inferiority Randomized Controlled Trial
The goal of this multicenter non-inferiority randomized controlled trial is to compare the efficacy of phacoemulsification with intraocular lens implantation (PEI) combined with goniotomy (GT) and PEI combined with medical therapy (MED) in the treatment of medically-controlled primary open-angle glaucoma (POAG) with cataract. The main questions it aims to answer are:
- Whether the PEI+GT was non-inferior to PEI+MED with regard to the intraocular pressure lowering effect in medically-controlled POAG.
- Whether the PEI+GT has value of health economics. Participants will be randomized to receive either PEI+GT or PEI+MED, and followed up with a 1-year period as a primary outcome.
Read the detailed description
Glaucoma is the leading cause of irreversible blindness worldwide, with primary open-angle glaucoma (POAG) remaining the most common subtype.
Although there are various methods to treat POAG, medication remains the first choice. However, medication therapy has several limitations, such as multiple adverse effects, poor compliance, and high costs. Therefore, it is imperative to explore treatment modalities that reduce medication burden and improve patients' quality of life.
Minimally invasive glaucoma surgery (MIGS) has been widely employed in clinical practice in recent years and become the mainstream surgical approach for POAG treatment. Among them, various forms of Schlemm's canal-based procedures, which were commonly known as ab interno trabeculotomy or goniotomy (GT) have garnered clinical significance due to their advantages of simplicity, minimal invasiveness, low complication rates, and rapid recovery. These procedures can also be combined with phacoemulsification with intraocular lens implantation (PEI). Currently, several GT techniques have been reported using different devices with different ranges of incision. The investigators have proved that a 120-degree GT with or with PEI were effective enough to treat patients with POAG with or without cataract, providing a comparable efficacy with 240 or 360 degree GT. The 120-degree is characterized by not only its efficacy, but also its fewer complications, faster procedure and quicker recovery. Although the techniques have been implemented clinically, further research is needed to evaluate their economics value in terms of reducing patient dependence on medication, relieving the economic burden of glaucoma medications, and improving the quality of life.
Therefore, a non-inferiority randomized controlled trial (RCT) will be conducted in medically controlled POAG patients with cataract, comparing PEI+GT to PEI combined with medication therapy (PEI+MED). The trial aims to validate the effectiveness of GT in reducing medication use, lightening the burden on patients, and providing a novel treatment approach.
- Conditions
- Glaucoma, Open-Angle, Cataract Complicated, Goniotomy
- Being tested
- PEI+GT, PEI+MED
- Keywords
- Glaucoma, Open-Angle, Cataract, Goniotomy, Minimally invasive glaucoma surgery
- Medical subject headings
- Glaucoma, Open-Angle, Capsule Opacification, Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEI+GTProcedure or surgery
After a standard phacoemulsification with intraocular lens implantation (PEI) is performed. The viscoelastic substance will be injected into the anterior chamber again to maintain corneal rigidity. The surgical microscope will be adjusted to tilt 35-40° towards the patient's nasal side, and the patient's head position will be adjusted to tilt 35-40° accordingly. A viscoelastic substance will be applied to the corneal surface to facilitate direct visualization of the angle structures under a gonioscope. The Tanito Microhook will be inserted through the main incision into the anterior chamber, and under gonioscopic guidance, the nasal (or inferonasal) trabecular meshwork and the inner wall of Schlemm's canal will be incised, approximately 120° in extent (60° in each direction).
PEI+MEDProcedure or surgery
Participants assigned to control group will undergo routine PEI surgery. Postoperatively, the decision to administer anti-glaucoma medication is based on intraocular pressure (IOP) measurements, and the target IOP is set at 16 mmHg. The selection of medications is informed by the Asia Pacific Glaucoma Guidelines (Kugler Publications, 2016), while the target IOP reference is the European Glaucoma Guidelines.
| Study group | Role | What they receive |
|---|---|---|
| PEI+GT | Experimental | Experimental group: Phacoemulsification with intraocular lens implantation (PEI) and goniotomy (GT). Receives: Procedure: PEI+GT |
| PEI+MED | Active comparator | Controll group: Phacoemulsification with intraocular lens implantation (PEI) and medication therapy (MED). Receives: Procedure: PEI+MED |
What is being measured
The primary outcome is the main question the study is designed to answer.
IOP at 12 months after surgery.
The intraocular pressure (mmHg) at 12 months after surgery.
Measured: Postopertive 12 months.
Secondary outcomes (3)
Surgery success of surgery
(i) Complete success (%) is defined as the postoperative 5 < IOP ≤ 16 mmHg with no need for IOP-lowering medication, without any vision-threatening complication or need for re-operation.
(ii) Qualified success (%) is defined as the postoperative 5 < IOP ≤ 16 mmHg regardless of IOP-lowering medication, without any vision-threatening complication or need for re-operation.
Measured: Postoperative 3, 6, 12 months.
Amount of postoperative anti-glaucomatous medications
The amount of postoperative anti-glaucomatous medications will be measured as: types of medication (No.) × time (No.).
Measured: Postoperative 1, 3, 6, 12 months.
Cost-effectiveness associated parameters
Cost-effectiveness associated parameters: cost of surgery and medications; quality-adjusted life year, etc.
Measured: Postoperative 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2024
- Study start28 Sep 2023
- Primary completion30 Sep 2026 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glaucoma, Open-AngleStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen 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
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Collaborators
- West China Hospital, Chongqing Medical University, The Second Hospital of Anhui Medical University, Handan City Eye Hospital, Shijiazhuang People's Hospital, Chengdu First People's Hospital, Guangdong Hospital of Traditional Chinese Medicine, Zhuhai, Joint Shantou International Eye Center of Shantou University and the Chinese University of Hong Kong, Huizhou Municipal Central Hospital
- Responsible party
- Principal investigator, Xiulan Zhang, Zhongshan Ophthalmic Center, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06201455
- Sponsor's protocol ID
- 2023KYPJ268
- Acronym
- ECO
- Status last verified
- Dec 2024
- First submitted
- 27 Aug 2023
- Last updated
- 11 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Phacogoniotomy in Medically-controlled Primary Open-angle Glaucoma With Cataract a Multicenter Non-inferiority Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06201455
- Acronym / sponsor ID
- ECO / 2023KYPJ268
- Conditions
- Glaucoma, Open-Angle, Cataract Complicated, Goniotomy
- Keywords
- Glaucoma, Open-Angle, Cataract, Goniotomy, Minimally invasive glaucoma surgery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Collaborators
- West China Hospital, Chongqing Medical University, The Second Hospital of Anhui Medical University, Handan City Eye Hospital, Shijiazhuang People's Hospital, Chengdu First People's Hospital, Guangdong Hospital of Traditional Chinese Medicine, Zhuhai, Joint Shantou International Eye Center of Shantou University and the Chinese University of Hong Kong, Huizhou Municipal Central Hospital
- Study start
- 28 Sep 2023 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 11 Jan 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 multicenter non-inferiority randomized controlled trial is to compare the efficacy of phacoemulsification with intraocular lens implantation (PEI) combined with goniotomy (GT) and PEI combined with medical therapy (MED) in the treatment of medically-controlled primary open-angle glaucoma (POAG) with cataract. The main questions it aims to answer are:
- Whether the PEI+GT was non-inferior to PEI+MED with regard to the intraocular pressure lowering effect in medically-controlled POAG.
- Whether the PEI+GT has value of health economics. Participants will be randomized to receive either PEI+GT or PEI+MED, and followed up with a 1-year period as a primary outcome.
Detailed description
Glaucoma is the leading cause of irreversible blindness worldwide, with primary open-angle glaucoma (POAG) remaining the most common subtype.
Although there are various methods to treat POAG, medication remains the first choice. However, medication therapy has several limitations, such as multiple adverse effects, poor compliance, and high costs. Therefore, it is imperative to explore treatment modalities that reduce medication burden and improve patients' quality of life.
Minimally invasive glaucoma surgery (MIGS) has been widely employed in clinical practice in recent years and become the mainstream surgical approach for POAG treatment. Among them, various forms of Schlemm's canal-based procedures, which were commonly known as ab interno trabeculotomy or goniotomy (GT) have garnered clinical significance due to their advantages of simplicity, minimal invasiveness, low complication rates, and rapid recovery. These procedures can also be combined with phacoemulsification with intraocular lens implantation (PEI). Currently, several GT techniques have been reported using different devices with different ranges of incision. The investigators have proved that a 120-degree GT with or with PEI were effective enough to treat patients with POAG with or without cataract, providing a comparable efficacy with 240 or 360 degree GT. The 120-degree is characterized by not only its efficacy, but also its fewer complications, faster procedure and quicker recovery. Although the techniques have been implemented clinically, further research is needed to evaluate their economics value in terms of reducing patient dependence on medication, relieving the economic burden of glaucoma medications, and improving the quality of life.
Therefore, a non-inferiority randomized controlled trial (RCT) will be conducted in medically controlled POAG patients with cataract, comparing PEI+GT to PEI combined with medication therapy (PEI+MED). The trial aims to validate the effectiveness of GT in reducing medication use, lightening the burden on patients, and providing a novel treatment approach.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PEI+GT | Experimental | Procedure: PEI+GTExperimental group: Phacoemulsification with intraocular lens implantation (PEI) and goniotomy (GT). |
| PEI+MED | Active comparator | Procedure: PEI+MEDControll group: Phacoemulsification with intraocular lens implantation (PEI) and medication therapy (MED). |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 40 ≤ Age ≤ 85 years, gender unrestricted.
- Diagnosed with POAG.
- Controlled IOP under 1 to 4 topical hypotensive medications, IOP ≤ 24 mmHg
- Mean deviation (MD) for perimetry ≥ -16dB.
- Presence of clinically significant cataract and best-corrected visual acuity measured using the ETDRS chart ≤ 0.63.
Key exclusion criteria (8 listed)
- Any history of intraocular surgery or ocular trauma.
- Presence of other types of glaucoma, including primary angle-closure glaucoma and various forms of secondary glaucoma (e.g. secondary angle-closure, pigmentary, steroid-induced, angle-recession, neovascular, inflammatory, and pseudoexfoliation syndrome).
- Presence of severe ocular diseases of various types that affect the acquisition of ocular parameters or interfere with perimetry.
- Axial length > 28 mm.
- Monophthalmia (best-corrected visual acuity of the non-study eye < 0.01).
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 |
|---|---|---|
| PEI+GTAfter a standard phacoemulsification with intraocular lens implantation (PEI) is performed. The viscoelastic substance will be injected into the anterior chamber again to maintain corneal rigidity. The surgical microscope will be adjusted to tilt 35-40° towards the patient's nasal side, and the patient's head position will be adjusted to tilt 35-40° accordingly. A viscoelastic substance will be applied to the corneal surface to facilitate direct visualization of the angle structures under a gonioscope. The Tanito Microhook will be inserted through the main incision into the anterior chamber, and under gonioscopic guidance, the nasal (or inferonasal) trabecular meshwork and the inner wall of Schlemm's canal will be incised, approximately 120° in extent (60° in each direction). | Procedure or surgery | PEI+GT |
| PEI+MEDParticipants assigned to control group will undergo routine PEI surgery. Postoperatively, the decision to administer anti-glaucoma medication is based on intraocular pressure (IOP) measurements, and the target IOP is set at 16 mmHg. The selection of medications is informed by the Asia Pacific Glaucoma Guidelines (Kugler Publications, 2016), while the target IOP reference is the European Glaucoma Guidelines. | Procedure or surgery | PEI+MED |
Primary outcome
IOP at 12 months after surgery.
Time frame: Postopertive 12 months.
The intraocular pressure (mmHg) at 12 months after surgery.
3 secondary outcomes
Surgery success of surgery
Time frame: Postoperative 3, 6, 12 months.
Amount of postoperative anti-glaucomatous medications
Time frame: Postoperative 1, 3, 6, 12 months.
Cost-effectiveness associated parameters
Time frame: Postoperative 12 months.
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 11 Dec 2024.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PEI+GT and PEI+MED in people with Glaucoma, Open-Angle and Cataract Complicated, run by Sun Yat-sen University at 1 site in China.
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 6 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 11 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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.
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 Xiulan Zhang, MD. PhD (+86 13570166308, zhangxl2@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IOP at 12 months after surgery. (time frame: Postopertive 12 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Dec 2024.