CataractNCT06739343
Comparison of Phaco-Trabeculectomy and MSICS-Trab in Cataract and Glaucoma Patients
A study testing PHACO-Trabeculectomy and MSICS-Trabeculectomy in people with Cataract and Glaucoma, run by Emeka John Dingwoke at 1 site in Nigeria.
Trial summary
The goal of this interventional study is to compare the outcomes of two surgical techniques, Phaco-Trabeculectomy and Manual Small Incision Cataract Surgery (MSICS) with Trabeculectomy, in patients with coexisting cataract and glaucoma at ECWA Eye Hospital, Kano, Nigeria. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- PHACO-Trabeculectomy and MSICS-Trabeculectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 1 siteNigeria
- Study dates
- 21 Sep 2022to 30 Sep 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients aged ≥18 years.
- Patients diagnosed with coexisting cataracts and primary open-angle glaucoma.
- Patients who have provided informed consent to participate in the study.
Who cannot join
- Patients with angle-closure glaucoma.
- Patients with secondary glaucoma or glaucoma-associated ocular or systemic anomalies.
- Patients with a history of ocular surgeries, such as trabeculectomy, cataract surgery, or other glaucoma surgeries.
- Patients with corneal or anterior segment diseases that could impede detailed examination (e.g., scleritis, bullous keratopathy, corneal scarring, corneal degenerations, or uveitis).
- Patients with posterior segment diseases affecting visual interpretation (e.g., diabetic retinopathy, hypertensive retinopathy, high axial myopia, retinal detachment, vitreous hemorrhage, macular degeneration, central retinal vein occlusion, or sickle cell retinopathy).
- Patients unwilling to provide voluntary informed consent or those who chose to withdraw from the study at any point.
- Patients with only one functional eye.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Phaco-Trabeculectomy Versus Combined Manual Small Incision Cataract Surgery with Trabeculectomy in Patients with Coexisting Cataract and Glaucoma At ECWA Eye Hospital, Kano, Nigeria
The goal of this interventional study is to compare the outcomes of two surgical techniques, Phaco-Trabeculectomy and Manual Small Incision Cataract Surgery (MSICS) with Trabeculectomy, in patients with coexisting cataract and glaucoma at ECWA Eye Hospital, Kano, Nigeria. The study aims to evaluate which technique offers better intraocular pressure (IOP) control, visual acuity improvement, and complication rates postoperatively.
The main questions the study seeks to answer are:
Read more
Does Phaco-Trabeculectomy provide superior IOP control compared to MSICS-Trabeculectomy in patients with coexisting cataract and glaucoma? Which technique is associated with fewer postoperative complications? How do the visual outcomes compare between the two techniques? Participants will be randomly assigned to undergo one of the two surgical techniques based on a predefined protocol. Data will be collected on intraoperative and postoperative parameters, including IOP, visual acuity, and the incidence of complications, with follow-ups extending over a 12-month period.
This study aims to provide evidence to guide clinicians in selecting the most effective and safe surgical approach for managing patients with cataract and glaucoma in resource-limited settings.
Read the detailed description
Background and Rationale Cataract and glaucoma are two of the leading causes of preventable blindness globally, presenting significant public health challenges, particularly in resource-limited settings such as Nigeria. The coexistence of cataract and glaucoma complicates surgical management, as cataract surgery alone may improve visual acuity but is insufficient to achieve long-term control of intraocular pressure (IOP) in glaucoma patients.
Combined surgical procedures, such as Phaco-Trabeculectomy and Manual Small Incision Cataract Surgery (MSICS) with Trabeculectomy, have been adopted to address these dual ocular conditions in a single intervention. However, evidence comparing the efficacy, safety, and long-term outcomes of these two approaches remains limited, particularly in Sub-Saharan Africa. This study seeks to bridge this critical gap in clinical evidence by generating region-specific data to optimize surgical decision-making for patients with coexisting cataract and glaucoma.
ECWA Eye Hospital, Kano, a tertiary eye care center in Nigeria renowned for its excellence in ophthalmology, provides the ideal setting for conducting this interventional study.
Study Objectives
This study aims to:
Determine whether Phaco-Trabeculectomy or MSICS-Trabeculectomy offers superior intraocular pressure (IOP) control in patients with coexisting cataract and glaucoma.
Compare the visual acuity outcomes between the two surgical techniques. Evaluate and compare the incidence of postoperative complications, such as bleb failure, hypotony, and infection.
Assess patient satisfaction and quality of life using validated questionnaires.
Study Design
This is a randomized, parallel-group, interventional study conducted over a 12-month follow-up period. Eligible participants are randomized into two arms using a block randomization approach to ensure balanced allocation:
Phaco-Trabeculectomy Group MSICS-Trabeculectomy Group Randomization minimizes selection bias and ensures comparability of baseline characteristics between groups.
Key Surgical Interventions Phaco-Trabeculectomy This procedure integrates phacoemulsification, a modern cataract extraction technique, with trabeculectomy to achieve IOP control.
A 3.2 mm corneal incision is made for ultrasonic emulsification and aspiration of the cataract.
A trabeculectomy is performed to create a filtration bleb, facilitating aqueous humor drainage.
This method is precise, minimally invasive, and well-suited for modern ophthalmic practice.
MSICS-Trabeculectomy This procedure combines manual extracapsular cataract extraction with trabeculectomy and is particularly advantageous in resource-limited settings.
A fornix-based conjunctival flap is raised, and a larger manual incision is made to remove the cataract nucleus.
Trabeculectomy is performed using the same technique as in the Phaco-Trabeculectomy group.
The MSICS-Trabeculectomy approach is practical, cost-effective, and suitable for environments where phacoemulsification equipment is unavailable.
Postoperative Management
Standardized postoperative care includes:
Administration of topical corticosteroids, antibiotics, and anti-glaucoma medications to reduce inflammation, prevent infection, and manage IOP.
Follow-up visits conducted on day 1, week 1, months 1, 3, 6, and 12 to assess clinical outcomes and monitor for complications, including hypotony, bleb failure, and infection.
Bleb morphology is evaluated using validated grading systems, while patient satisfaction and quality of life are assessed using standardized questionnaires.
Data Collection and Analysis
Data on surgical outcomes, including IOP, visual acuity, and postoperative complications, are systematically collected at predefined intervals. Statistical tools are employed for comparative analysis:
Continuous variables such as IOP and visual acuity are analyzed using paired and unpaired t-tests.
Categorical variables, including complication rates, are analyzed using chi-square tests and logistic regression models.
Results will be presented as mean ± standard deviation for continuous variables and as percentages for categorical variables.
Significance of the Study
This study provides a direct comparative analysis of Phaco-Trabeculectomy and MSICS-Trabeculectomy in a Sub-Saharan African context. By evaluating clinical efficacy, cost-effectiveness, and patient-reported outcomes, the findings will:
Inform clinical practice by identifying the optimal surgical approach for managing coexisting cataract and glaucoma.
Address regional gaps in evidence-based ophthalmic care, particularly in resource-limited settings.
Serve as a foundation for further studies exploring long-term surgical outcomes and innovations in glaucoma-cataract management.
Novel Contributions
This study is one of the first to comprehensively evaluate two combined surgical techniques in a Sub-Saharan African population. Its strengths include:
Rigorous randomization to ensure unbiased comparisons. Systematic data collection at predefined intervals over 12 months. Use of validated tools for assessing bleb morphology, complications, and patient satisfaction.
By bridging the gap in clinical evidence, this study has the potential to improve surgical decision-making, enhance patient outcomes, and guide ophthalmic care strategies in resource-constrained settings.
Conclusion This interventional study will provide critical insights into the comparative effectiveness and safety of Phaco-Trabeculectomy and MSICS-Trabeculectomy for managing coexisting cataract and glaucoma. Its findings are expected to have significant implications for ophthalmic practice in Nigeria and other resource-limited regions, ultimately contributing to the prevention of avoidable blindness.
- Being tested
- PHACO-Trabeculectomy, MSICS-Trabeculectomy
- Keywords
- Cataract, Glaucoma, Phaco-Trabeculectomy, MSICS-Trabeculectomy, Intraocular Pressure, Visual Acuity, ECWA Eye Hospital, Surgical Outcomes, Combined Surgery, Ophthalmology
- Medical subject headings
- Cataract, Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PHACO-TrabeculectomyProcedure or surgery
Phaco-Trabeculectomy is a combined surgical procedure that integrates phacoemulsification, a modern cataract extraction technique using ultrasound, with trabeculectomy, a glaucoma filtration surgery. This intervention is distinguished by its precision, minimal incision size, and suitability for patients with coexisting cataract and glaucoma. Phacoemulsification efficiently emulsifies and aspirates the cataract through a small incision, while trabeculectomy creates a filtration bleb to lower intraocular pressure (IOP). This combination allows for simultaneous management of both conditions, particularly in cases where phacoemulsification is preferred for cataract extraction.
MSICS-TrabeculectomyProcedure or surgery
Manual Small Incision Cataract Surgery (MSICS) with Trabeculectomy is a cost-effective, combined surgical approach involving a manual technique for cataract removal alongside glaucoma filtration surgery. MSICS utilizes a larger incision than phacoemulsification, allowing for the manual extraction of the cataract nucleus. This procedure is particularly advantageous in resource-limited settings where phacoemulsification equipment may not be available. The trabeculectomy component is the same as in the PHACO-Trabeculectomy intervention, providing effective IOP reduction through the creation of a filtration bleb.
| Study group | Role | What they receive |
|---|---|---|
| PHACO-Trabeculectomy Group | Active comparator | Participants in this group underwent Phaco-Trabeculectomy, a combined surgical procedure that involves phacoemulsification (modern cataract extraction technique) and trabeculectomy (a glaucoma filtration surgery). This procedure is designed to address both cataract removal and intraocular pressure (IOP) reduction in a single surgery.
Interventions:
Phacoemulsification: Ultrasound-based cataract removal. Trabeculectomy: Creation of a filtration bleb to lower IOP. Receives: Procedure: PHACO-Trabeculectomy; Procedure: MSICS-Trabeculectomy |
| MSICS-Trabeculectomy Group | Active comparator | Participants in this group underwent Manual Small Incision Cataract Surgery (MSICS) combined with trabeculectomy. This procedure, which uses a manual technique for cataract extraction, is often more cost-effective and suitable for resource-limited settings while also addressing IOP reduction.
Interventions:
Manual Small Incision Cataract Surgery (MSICS): A manual extracapsular cataract extraction technique.
Trabeculectomy: Same filtration procedure as in the Phaco-Trabeculectomy group to manage glaucoma. Receives: Procedure: PHACO-Trabeculectomy; Procedure: MSICS-Trabeculectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Intraocular Pressure (IOP)
The primary outcome measure is the change in intraocular pressure (IOP) from baseline to 12 months postoperatively. IOP will be measured using the Goldmann Applanation Tonometer, the gold standard for IOP measurement. Measurements will be recorded in millimeters of mercury (mmHg).
The change in intraocular pressure (IOP) will reflect the effectiveness of the surgical intervention in controlling IOP over time. Lower IOP values within the normal range (10-21 mmHg) indicate successful pressure regulation and better surgical outcomes, reducing the risk of glaucoma progression. Conversely, persistently elevated IOP values may suggest surgical failure
The changes in IOP will be compared between the Phaco-Trabeculectomy and MSICS-Trabeculectomy groups to assess the efficacy of each surgical technique in controlling intraocular pressure over the study duration.
Measured: Baseline, Day 1, Week 1, Month 1, Month 3, Month 6, and Month 12 post-surgery. To determine the relative effectiveness of the two surgical techniques in managing glaucoma-related elevated IOP.
Secondary outcomes (3)
Best-Corrected Visual Acuity (BCVA)
Secondary outcomes include the improvement in best-corrected visual acuity (BCVA), measured using the Snellen chart.
BCVA is expressed in logMAR units, with lower logMAR values reflecting better visual acuity.
For instance, a logMAR of 0.1 corresponds to good vision (6/7.5), while higher values indicate worsening acuity.
Measured: Baseline, Month 1, Month 3, Month 6, and Month 12 post-surgery
Postoperative Complications
Hypotony will be recorded and compared between the two groups. Hypotony: Defined as intraocular pressure (IOP) <5 mmHg, will be measured using the Goldmann tonometer (unit: mmHg). Lower IOP values below 5 mmHg indicate hypotony. Higher IOP values within the normal range (10-21 mmHg) reflect better intraocular pressure control and stable ocular function.
Measured: Day 1, Week 1, Month 1, Month 3, Month 6, and Month 12 post-surgery.
Bleb Function
Assessment of the filtration bleb's functionality will be done using the Indiana Bleb Appearance Grading Scale (IBAGS). This standardized grading system evaluates bleb vascularity (graded V0-V4).
Lower grades (V0-V1) indicate minimal or no vascularity, suggesting a healthy and functional bleb, which is favorable for successful aqueous humor drainage and intraocular pressure control. Higher grades (V3-V4) reflect increased vascularity, which may signal inflammation.
Measured: Month 1, Month 3, Month 6, and Month 12 post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2024
- Study start21 Sep 2022
- Primary completion30 Sep 2024
- Study completion30 Sep 2024
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 CataractStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study follows a parallel group design, where eligible participants are randomly assigned to one of two independent intervention arms: the Phaco-Trabeculectomy group or the MSICS-Trabeculectomy group. Each group receives a distinct surgical intervention, and participants remain in their assigned groups throughout the study duration. Outcomes are measured and compared between the two groups to evaluate the relative effectiveness and safety of the interventions.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emeka John Dingwoke
- Sponsor type
- University, hospital or other
- Collaborators
- Ahmadu Bello University Teaching Hospital
- Responsible party
- Sponsor-investigator, Emeka John Dingwoke, UNESCO International Centre for Biotechnology, Nigeria
- Investigators
- Mayor Orezime Atima, FWACS, Study chair, ECWA Eye Hospital, Kano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06739343
- Sponsor's protocol ID
- ECWA/HREC/004/2022
- Status last verified
- Dec 2024
- First submitted
- 11 Dec 2024
- Last updated
- 18 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data (IPD) related to primary and secondary outcome measures will be shared with researchers upon reasonable request. Data will be anonymized and made available through a secure repository following approval of a data-sharing agreement.
Publications
Munaje MI, Aribaba OT, Atima MO, Idakwo U, Pam JD, Dingwoke EJ, Gandi NB. Phaco-trabeculectomy versus MSICS-trabeculectomy for coexisting cataract and glaucoma: visual and IOP outcomes from a randomized trial in Nigeria. BMC Ophthalmol. 2025 Nov 5;25(1):621. doi: 10.1186/s12886-025-04482-1.
PubMed 41194003
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Phaco-Trabeculectomy Versus Combined Manual Small Incision Cataract Surgery with Trabeculectomy in Patients with Coexisting Cataract and Glaucoma At ECWA Eye Hospital, Kano, Nigeria
- ClinicalTrials.gov ID
- NCT06739343
- Acronym / sponsor ID
- ECWA/HREC/004/2022
- Keywords
- Cataract, Glaucoma, Phaco-Trabeculectomy, MSICS-Trabeculectomy, Intraocular Pressure, Visual Acuity, ECWA Eye Hospital, Surgical Outcomes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Emeka John DingwokeUniversity, hospital or other
- Collaborators
- Ahmadu Bello University Teaching Hospital
- Study start
- 21 Sep 2022 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 18 Dec 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 interventional study is to compare the outcomes of two surgical techniques, Phaco-Trabeculectomy and Manual Small Incision Cataract Surgery (MSICS) with Trabeculectomy, in patients with coexisting cataract and glaucoma at ECWA Eye Hospital, Kano, Nigeria. The study aims to evaluate which technique offers better intraocular pressure (IOP) control, visual acuity improvement, and complication rates postoperatively.
The main questions the study seeks to answer are:
Does Phaco-Trabeculectomy provide superior IOP control compared to MSICS-Trabeculectomy in patients with coexisting cataract and glaucoma? Which technique is associated with fewer postoperative complications? How do the visual outcomes compare between the two techniques? Participants will be randomly assigned to undergo one of the two surgical techniques based on a predefined protocol. Data will be collected on intraoperative and postoperative parameters, including IOP, visual acuity, and the incidence of complications, with follow-ups extending over a 12-month period.
This study aims to provide evidence to guide clinicians in selecting the most effective and safe surgical approach for managing patients with cataract and glaucoma in resource-limited settings.
Detailed description
Background and Rationale Cataract and glaucoma are two of the leading causes of preventable blindness globally, presenting significant public health challenges, particularly in resource-limited settings such as Nigeria. The coexistence of cataract and glaucoma complicates surgical management, as cataract surgery alone may improve visual acuity but is insufficient to achieve long-term control of intraocular pressure (IOP) in glaucoma patients.
Combined surgical procedures, such as Phaco-Trabeculectomy and Manual Small Incision Cataract Surgery (MSICS) with Trabeculectomy, have been adopted to address these dual ocular conditions in a single intervention. However, evidence comparing the efficacy, safety, and long-term outcomes of these two approaches remains limited, particularly in Sub-Saharan Africa. This study seeks to bridge this critical gap in clinical evidence by generating region-specific data to optimize surgical decision-making for patients with coexisting cataract and glaucoma.
ECWA Eye Hospital, Kano, a tertiary eye care center in Nigeria renowned for its excellence in ophthalmology, provides the ideal setting for conducting this interventional study.
Study Objectives
This study aims to:
Determine whether Phaco-Trabeculectomy or MSICS-Trabeculectomy offers superior intraocular pressure (IOP) control in patients with coexisting cataract and glaucoma.
Compare the visual acuity outcomes between the two surgical techniques. Evaluate and compare the incidence of postoperative complications, such as bleb failure, hypotony, and infection.
Assess patient satisfaction and quality of life using validated questionnaires.
Study Design
This is a randomized, parallel-group, interventional study conducted over a 12-month follow-up period. Eligible participants are randomized into two arms using a block randomization approach to ensure balanced allocation:
Phaco-Trabeculectomy Group MSICS-Trabeculectomy Group Randomization minimizes selection bias and ensures comparability of baseline characteristics between groups.
Key Surgical Interventions Phaco-Trabeculectomy This procedure integrates phacoemulsification, a modern cataract extraction technique, with trabeculectomy to achieve IOP control.
A 3.2 mm corneal incision is made for ultrasonic emulsification and aspiration of the cataract.
A trabeculectomy is performed to create a filtration bleb, facilitating aqueous humor drainage.
This method is precise, minimally invasive, and well-suited for modern ophthalmic practice.
MSICS-Trabeculectomy This procedure combines manual extracapsular cataract extraction with trabeculectomy and is particularly advantageous in resource-limited settings.
A fornix-based conjunctival flap is raised, and a larger manual incision is made to remove the cataract nucleus.
Trabeculectomy is performed using the same technique as in the Phaco-Trabeculectomy group.
The MSICS-Trabeculectomy approach is practical, cost-effective, and suitable for environments where phacoemulsification equipment is unavailable.
Postoperative Management
Standardized postoperative care includes:
Administration of topical corticosteroids, antibiotics, and anti-glaucoma medications to reduce inflammation, prevent infection, and manage IOP.
Follow-up visits conducted on day 1, week 1, months 1, 3, 6, and 12 to assess clinical outcomes and monitor for complications, including hypotony, bleb failure, and infection.
Bleb morphology is evaluated using validated grading systems, while patient satisfaction and quality of life are assessed using standardized questionnaires.
Data Collection and Analysis
Data on surgical outcomes, including IOP, visual acuity, and postoperative complications, are systematically collected at predefined intervals. Statistical tools are employed for comparative analysis:
Continuous variables such as IOP and visual acuity are analyzed using paired and unpaired t-tests.
Categorical variables, including complication rates, are analyzed using chi-square tests and logistic regression models.
Results will be presented as mean ± standard deviation for continuous variables and as percentages for categorical variables.
Significance of the Study
This study provides a direct comparative analysis of Phaco-Trabeculectomy and MSICS-Trabeculectomy in a Sub-Saharan African context. By evaluating clinical efficacy, cost-effectiveness, and patient-reported outcomes, the findings will:
Inform clinical practice by identifying the optimal surgical approach for managing coexisting cataract and glaucoma.
Address regional gaps in evidence-based ophthalmic care, particularly in resource-limited settings.
Serve as a foundation for further studies exploring long-term surgical outcomes and innovations in glaucoma-cataract management.
Novel Contributions
This study is one of the first to comprehensively evaluate two combined surgical techniques in a Sub-Saharan African population. Its strengths include:
Rigorous randomization to ensure unbiased comparisons. Systematic data collection at predefined intervals over 12 months. Use of validated tools for assessing bleb morphology, complications, and patient satisfaction.
By bridging the gap in clinical evidence, this study has the potential to improve surgical decision-making, enhance patient outcomes, and guide ophthalmic care strategies in resource-constrained settings.
Conclusion This interventional study will provide critical insights into the comparative effectiveness and safety of Phaco-Trabeculectomy and MSICS-Trabeculectomy for managing coexisting cataract and glaucoma. Its findings are expected to have significant implications for ophthalmic practice in Nigeria and other resource-limited regions, ultimately contributing to the prevention of avoidable blindness.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- This study follows a parallel group design, where eligible participants are randomly assigned to one of two independent intervention arms: the Phaco-Trabeculectomy group or the MSICS-Trabeculectomy group. Each group receives a distinct surgical intervention, and participants remain in their assigned groups throughout the study duration. Outcomes are measured and compared between the two groups to evaluate the relative effectiveness and safety of the interventions.
| Arm | Type | Receives |
|---|---|---|
| PHACO-Trabeculectomy Group | Active comparator | Procedure: PHACO-Trabeculectomy, Procedure: MSICS-TrabeculectomyParticipants in this group underwent Phaco-Trabeculectomy, a combined surgical procedure that involves phacoemulsification (modern cataract extraction technique) and trabeculectomy (a glaucoma filtration surgery). This procedure is designed to address both cataract removal and intraocular pressure (IOP) reduction in a single surgery. Interventions: Phacoemulsification: Ultrasound-based cataract removal. Trabeculectomy: Creation of a filtration bleb to lower IOP. |
| MSICS-Trabeculectomy Group | Active comparator | Procedure: PHACO-Trabeculectomy, Procedure: MSICS-TrabeculectomyParticipants in this group underwent Manual Small Incision Cataract Surgery (MSICS) combined with trabeculectomy. This procedure, which uses a manual technique for cataract extraction, is often more cost-effective and suitable for resource-limited settings while also addressing IOP reduction. Interventions: Manual Small Incision Cataract Surgery (MSICS): A manual extracapsular cataract extraction technique. Trabeculectomy: Same filtration procedure as in the Phaco-Trabeculectomy group to manage glaucoma. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients aged ≥18 years.
- Patients diagnosed with coexisting cataracts and primary open-angle glaucoma.
- Patients who have provided informed consent to participate in the study.
Key exclusion criteria (7 listed)
- Patients with angle-closure glaucoma.
- Patients with secondary glaucoma or glaucoma-associated ocular or systemic anomalies.
- Patients with a history of ocular surgeries, such as trabeculectomy, cataract surgery, or other glaucoma surgeries.
- Patients with corneal or anterior segment diseases that could impede detailed examination (e.g., scleritis, bullous keratopathy, corneal scarring, corneal degenerations, or uveitis).
- Patients with posterior segment diseases affecting visual interpretation (e.g., diabetic retinopathy, hypertensive retinopathy, high axial myopia, retinal detachment, vitreous hemorrhage, macular degeneration, central retinal vein occlusion, or sickle cell retinopathy).
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 |
|---|---|---|
| PHACO-TrabeculectomyPhaco-Trabeculectomy is a combined surgical procedure that integrates phacoemulsification, a modern cataract extraction technique using ultrasound, with trabeculectomy, a glaucoma filtration surgery. This intervention is distinguished by its precision, minimal incision size, and suitability for patients with coexisting cataract and glaucoma. Phacoemulsification efficiently emulsifies and aspirates the cataract through a small incision, while trabeculectomy creates a filtration bleb to lower intraocular pressure (IOP). This combination allows for simultaneous management of both conditions, particularly in cases where phacoemulsification is preferred for cataract extraction. | Procedure or surgery | MSICS-Trabeculectomy Group, PHACO-Trabeculectomy Group |
| MSICS-TrabeculectomyManual Small Incision Cataract Surgery (MSICS) with Trabeculectomy is a cost-effective, combined surgical approach involving a manual technique for cataract removal alongside glaucoma filtration surgery. MSICS utilizes a larger incision than phacoemulsification, allowing for the manual extraction of the cataract nucleus. This procedure is particularly advantageous in resource-limited settings where phacoemulsification equipment may not be available. The trabeculectomy component is the same as in the PHACO-Trabeculectomy intervention, providing effective IOP reduction through the creation of a filtration bleb. | Procedure or surgery | MSICS-Trabeculectomy Group, PHACO-Trabeculectomy Group |
Primary outcome
Change in Intraocular Pressure (IOP)
Time frame: Baseline, Day 1, Week 1, Month 1, Month 3, Month 6, and Month 12 post-surgery. To determine the relative effectiveness of the two surgical techniques in managing glaucoma-related elevated IOP.
The primary outcome measure is the change in intraocular pressure (IOP) from baseline to 12 months postoperatively. IOP will be measured using the Goldmann Applanation Tonometer, the gold standard for IOP measurement. Measurements will be recorded in millimeters of mercury (mmHg). The change in intraocular pressure (IOP) will reflect the effectiveness of the surgical intervention in controlling IOP over time. Lower IOP values within the normal range (10-21 mmHg) indicate successful pressure regulation and better surgical outcomes, reducing the risk of glaucoma progression. Conversely, persistently elevated IOP values may suggest surgical failure The changes in IOP will be compared between the Phaco-Trabeculectomy and MSICS-Trabeculectomy groups to assess the efficacy of each surgical technique in controlling intraocular pressure over the study duration.
3 secondary outcomes
Best-Corrected Visual Acuity (BCVA)
Time frame: Baseline, Month 1, Month 3, Month 6, and Month 12 post-surgery
Postoperative Complications
Time frame: Day 1, Week 1, Month 1, Month 3, Month 6, and Month 12 post-surgery.
Bleb Function
Time frame: Month 1, Month 3, Month 6, and Month 12 post-surgery
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 18 Dec 2024.
- Derived from this study: PubMed 41194003Munaje MI, Aribaba OT, Atima MO, Idakwo U, Pam JD, Dingwoke EJ, Gandi NB. Phaco-trabeculectomy versus MSICS-trabeculectomy for coexisting cataract and glaucoma: visual and IOP outcomes from a randomized trial in Nigeria. BMC Ophthalmol. 2025 Nov 5;25(1):621. doi: 10.1186/s12886-025-04482-1.
- Individual participant dataSharing planned: Yes. Individual participant data (IPD) related to primary and secondary outcome measures will be shared with researchers upon reasonable request. Data will be anonymized and made available through a secure repository following approval of a data-sharing agreement.
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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.
Mayor Orezime Atima, FWACS study chair
ECWA Eye Hospital, Kano
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PHACO-Trabeculectomy and MSICS-Trabeculectomy in people with Cataract and Glaucoma, run by Emeka John Dingwoke at 1 site in Nigeria.
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: finished, as of the sponsor's last update on 18 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 Nigeria. 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?
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?
Change in Intraocular Pressure (IOP) (time frame: Baseline, Day 1, Week 1, Month 1, Month 3, Month 6, and Month 12 post-surgery. To determine the relative effectiveness of the two surgical techniques in managing glaucoma-related elevated IOP.). 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 NCT06739343, 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 18 Dec 2024.