Pediatric GlaucomaNCT05401760
Combined Phacoaspiration and Angle Surgery Versus Phacoaspiration in Pediatric Cataract
A study testing Group A :combined phacoaspiration and angle surgery and Group B : phacoaspiration only in people with Pediatric Glaucoma, run by Mansoura University at 1 site in Egypt.
Trial summary
The aim of this study is to report the effectiveness of phacoaspiration when combined with angle surgery in preventing postoperative glaucoma following pediatric cataract surgery Read more about this study
- Who is it for?
- Ages 1 month to 24 months
- Conditions the study is for
- Pediatric Glaucoma
- What is being tested?
- Group A :combined phacoaspiration and angle surgery and Group B : phacoaspiration only
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 30 May 2022to 1 Mar 2023
- 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 1 month to 24 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- pediatric congenital cataract Aged less than two years associated with other ocular anomalies which is high risk for developing glaucoma as microcornea and aniridia.
- pediatric cataract with other eye had post cataract surgery glaucoma
Who cannot join
- Acquired cataracts secondary to trauma or uveitis.
- Aged more than two years.
- Associated corneal opacities.
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to report the effectiveness of phacoaspiration when combined with angle surgery in preventing postoperative glaucoma following pediatric cataract surgery
Read the detailed description
As postoperative glaucoma could be the consequence of a dysgenesis of the iridocorneal angle that accompanies the dysgenesis of the lens so, the hypothesis states that combined phacoaspiration with angle surgery may be superior to phacoaspiration as standalone procedure in controlling IOP within the normal range postoperatively after pediatric cataract surgery
- Patients with pediatric cataract will be subdivided into 2 groups: Group A: includes eyes for whom combined phacoaspiration \& angle surgery will be done.
Group B: includes eyes for whom phacoaspiration only will be done. All surgeries will be performed in Mansoura Ophthalmic Center by the same surgeon or under his supervision.
Preoperative:
- History: Full ocular \& general history will be taken Ocular history: history of ocular trauma, ocular surgeries \& wearing glasses. General medical history: age, history of any associated neurologic, metabolic or systemic disease or drug intake.
- Examination: Full ocular examination will be done
- Anterior segment examination using (Topcon or Zeiss surgical microscopes) or (Zeiss or hag streit slit lamps).
- Corneal diameter will be measured.
- Fundus examination using indirect ophthalmoscope (KEELER Vantage Plus indirect ophthalmoscope) if the fundus is visible.
- IOP measuring using Schoitz tonometer.
- Refraction (if the eye can be refracted) \& K readings will be measured using portable autorefractometer (Retinomax K-plus2).
- Investigations:
- Axial length, anterior chamber depth \& Ocular biometry will be measured using (Nidek Al-Scan Optical Biometer).
- B-scan will be done using (Nidek Us-4000 Echoscan).
- Ultrasound biomicroscopy (UBM) scan will be performed using (VuMAX HD).
Intraoperative:
- Group A: for whom combined phacoaspiration \& angle surgery ither trabeculotomy will be done. I
- Partial thickness scleral flap to access the canal of schlemm.
- 2 side ports will be fashioned.
- Trypan blue will be injected to aid visualization of the anterior capsule \& continuous curvilinear anterior capsulorhexis of approximately 5.0 mm diameter will be done.
- The nucleus and cortex will be aspirated.
- Posterior capsulrehxis and limited anterior vitrectomy will be done.
- Corneal incisions will be sutured with 10-0 Nylon suture.
- Using metal trabeculotomes to open thetrabecular meshwork after accessing the canal of schlemm.
- Suturing of scleral flap with 10-0 Nylon suture.
- Group B: for whom phacoaspiration only will be done.
- 2 side ports will be fashioned.
- Trypan blue will be injected to aid visualization of the anterior capsule \& continuous curvilinear anterior capsulorhexis of approximately 5.0 mm diameter will be done.
- The nucleus and cortex will be aspirated.
- Posterior capsulrehxis and limited anterior vitrectomy will be done.
- Corneal incisions will be sutured with 10-0 Nylon suture.
Postoperative:
- All patients will be discharged on:
- Systemic \&topical antibiotic eye drops.
- Topical steroids.
- Cycloplegic eye drops.
- Combined antibiotic and steroid eye ointment.
- Topical Steroids \& cycloplegic eye drops will be gradually withdrawn over a period of 3 months.
- The eyes will be carefully examined at each follow-up visit (1 week, 2 weeks 1months and 3 months).
- During each visit:
- Anterior segment examination will be done.
- Measuring of:
- Corneal diameter.
- Cup/disc ratio.
- IOP using Schoitz tonometer.
- Axial length, anterior chamber depth.
- Conditions
- Pediatric Glaucoma
- Being tested
- Group A :combined phacoaspiration and angle surgery, Group B : phacoaspiration only
- Medical subject headings
- Hydrophthalmos
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group A :combined phacoaspiration and angle surgeryProcedure or surgery
- Partial thickness scleral flap to access the canal of schlemm.
- 2 side ports will be fashioned.
- Trypan blue will be injected to aid visualization of the anterior capsule \& continuous curvilinear anterior capsulorhexis of approximately 5.0 mm diameter will be done.
- The nucleus and cortex will be aspirated.
- Posterior capsulrehxis and limited anterior vitrectomy will be done.
- Corneal incisions will be sutured with 10-0 Nylon suture.
- Using metal trabeculotomes to open thetrabecular meshwork after accessing the canal of schlemm.
- Suturing of scleral flap with 10-0 Nylon suture.
Group B : phacoaspiration onlyProcedure or surgery
- 2 side ports will be fashioned.
- Trypan blue will be injected to aid visualization of the anterior capsule \& continuous curvilinear anterior capsulorhexis of approximately 5.0 mm diameter will be done.
- The nucleus and cortex will be aspirated.
- Posterior capsulrehxis and limited anterior vitrectomy will be done.
- Corneal incisions will be sutured with 10-0 Nylon suture.
| Study group | Role | What they receive |
|---|---|---|
| Group A: includes eyes for whom combined phacoaspiration & angle surgery will be done. | Active comparator | Group A: for whom combined phacoaspiration \& angle surgery trabeculotomy will be done.
* continuous curvilinear anterior capsulorhexis of approximately 5.0 mm diameter will be done.
* The nucleus and cortex will be aspirated.
* Posterior capsulrehxis and limited anterior vitrectomy will be done.
* Corneal incisions will be sutured with 10-0 Nylon suture.
* Using metal trabeculotomes to open thetrabecular meshwork after accessing the canal of schlemm.
* Suturing of scleral flap with 10-0 Nylon suture. Receives: Procedure: Group A :combined phacoaspiration and angle surgery |
| Group B : includes eyes with only phacoaspiration will be done | Active comparator | Group B: for whom phacoaspiration only will be done.
* 2 side ports will be fashioned.
* Trypan blue will be injected to aid visualization of the anterior capsule \& continuous curvilinear anterior capsulorhexis of approximately 5.0 mm diameter will be done.
* The nucleus and cortex will be aspirated.
* Posterior capsulrehxis and limited anterior vitrectomy will be done.
* Corneal incisions will be sutured with 10-0 Nylon suture. Receives: Procedure: Group B : phacoaspiration only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraocular pressure
glaucoma
Measured: up to one year follow up
Secondary outcomes (1)
rate of complications
hyphaema or intraocular inflammation
Measured: one year follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2022
- Study start30 May 2022
- Primary completion30 Nov 2022 (estimated)
- Study completion1 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric GlaucomaStudies of the same condition, open and under way.
- More trials run by Mansoura 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
- Model description
- Inclusion criteria: 1. Patients with pediatric congenital cataract Aged less than two years associated with other ocular anomalies which is high risk for developing PCSG as microcornea and aniridia. 2. Patient with pediatric cataract with other eye had post cataract surgery glaucoma
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dina abdelfattah, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05401760
- Sponsor's protocol ID
- R.22.05.1718
- Status last verified
- Sep 2022
- First submitted
- 16 May 2022
- Last updated
- 8 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: results of collected data
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Phacoaspiration and Angle Surgery Versus Phacoaspiration in Pediatric Cataract
- ClinicalTrials.gov ID
- NCT05401760
- Acronym / sponsor ID
- R.22.05.1718
- Conditions
- Pediatric Glaucoma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 30 May 2022 (actual)
- Primary completion
- 30 Nov 2022 (estimated)
- Study completion
- 1 Mar 2023 (estimated)
- First posted
- 2 Jun 2022 (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 aim of this study is to report the effectiveness of phacoaspiration when combined with angle surgery in preventing postoperative glaucoma following pediatric cataract surgery
Detailed description
As postoperative glaucoma could be the consequence of a dysgenesis of the iridocorneal angle that accompanies the dysgenesis of the lens so, the hypothesis states that combined phacoaspiration with angle surgery may be superior to phacoaspiration as standalone procedure in controlling IOP within the normal range postoperatively after pediatric cataract surgery
- Patients with pediatric cataract will be subdivided into 2 groups: Group A: includes eyes for whom combined phacoaspiration \& angle surgery will be done.
Group B: includes eyes for whom phacoaspiration only will be done. All surgeries will be performed in Mansoura Ophthalmic Center by the same surgeon or under his supervision.
Preoperative:
- History: Full ocular \& general history will be taken Ocular history: history of ocular trauma, ocular surgeries \& wearing glasses. General medical history: age, history of any associated neurologic, metabolic or systemic disease or drug intake.
- Examination: Full ocular examination will be done
- Anterior segment examination using (Topcon or Zeiss surgical microscopes) or (Zeiss or hag streit slit lamps).
- Corneal diameter will be measured.
- Fundus examination using indirect ophthalmoscope (KEELER Vantage Plus indirect ophthalmoscope) if the fundus is visible.
- IOP measuring using Schoitz tonometer.
- Refraction (if the eye can be refracted) \& K readings will be measured using portable autorefractometer (Retinomax K-plus2).
- Investigations:
- Axial length, anterior chamber depth \& Ocular biometry will be measured using (Nidek Al-Scan Optical Biometer).
- B-scan will be done using (Nidek Us-4000 Echoscan).
- Ultrasound biomicroscopy (UBM) scan will be performed using (VuMAX HD).
Intraoperative:
- Group A: for whom combined phacoaspiration \& angle surgery ither trabeculotomy will be done. I
- Partial thickness scleral flap to access the canal of schlemm.
- 2 side ports will be fashioned.
- Trypan blue will be injected to aid visualization of the anterior capsule \& continuous curvilinear anterior capsulorhexis of approximately 5.0 mm diameter will be done.
- The nucleus and cortex will be aspirated.
- Posterior capsulrehxis and limited anterior vitrectomy will be done.
- Corneal incisions will be sutured with 10-0 Nylon suture.
- Using metal trabeculotomes to open thetrabecular meshwork after accessing the canal of schlemm.
- Suturing of scleral flap with 10-0 Nylon suture.
- Group B: for whom phacoaspiration only will be done.
- 2 side ports will be fashioned.
- Trypan blue will be injected to aid visualization of the anterior capsule \& continuous curvilinear anterior capsulorhexis of approximately 5.0 mm diameter will be done.
- The nucleus and cortex will be aspirated.
- Posterior capsulrehxis and limited anterior vitrectomy will be done.
- Corneal incisions will be sutured with 10-0 Nylon suture.
Postoperative:
- All patients will be discharged on:
- Systemic \&topical antibiotic eye drops.
- Topical steroids.
- Cycloplegic eye drops.
- Combined antibiotic and steroid eye ointment.
- Topical Steroids \& cycloplegic eye drops will be gradually withdrawn over a period of 3 months.
- The eyes will be carefully examined at each follow-up visit (1 week, 2 weeks 1months and 3 months).
- During each visit:
- Anterior segment examination will be done.
- Measuring of:
- Corneal diameter.
- Cup/disc ratio.
- IOP using Schoitz tonometer.
- Axial length, anterior chamber depth.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Inclusion criteria: 1. Patients with pediatric congenital cataract Aged less than two years associated with other ocular anomalies which is high risk for developing PCSG as microcornea and aniridia. 2. Patient with pediatric cataract with other eye had post cataract surgery glaucoma
| Arm | Type | Receives |
|---|---|---|
| Group A: includes eyes for whom combined phacoaspiration & angle surgery will be done. | Active comparator | Procedure: Group A :combined phacoaspiration and angle surgeryGroup A: for whom combined phacoaspiration \& angle surgery trabeculotomy will be done. * continuous curvilinear anterior capsulorhexis of approximately 5.0 mm diameter will be done. * The nucleus and cortex will be aspirated. * Posterior capsulrehxis and limited anterior vitrectomy will be done. * Corneal incisions will be sutured with 10-0 Nylon suture. * Using metal trabeculotomes to open thetrabecular meshwork after accessing the canal of schlemm. * Suturing of scleral flap with 10-0 Nylon suture. |
| Group B : includes eyes with only phacoaspiration will be done | Active comparator | Procedure: Group B : phacoaspiration onlyGroup B: for whom phacoaspiration only will be done. * 2 side ports will be fashioned. * Trypan blue will be injected to aid visualization of the anterior capsule \& continuous curvilinear anterior capsulorhexis of approximately 5.0 mm diameter will be done. * The nucleus and cortex will be aspirated. * Posterior capsulrehxis and limited anterior vitrectomy will be done. * Corneal incisions will be sutured with 10-0 Nylon suture. |
Who may qualify
- Ages
- 1 month to 24 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- pediatric congenital cataract Aged less than two years associated with other ocular anomalies which is high risk for developing glaucoma as microcornea and aniridia.
- pediatric cataract with other eye had post cataract surgery glaucoma
Key exclusion criteria (3 listed)
- Acquired cataracts secondary to trauma or uveitis.
- Aged more than two years.
- Associated corneal opacities.
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 |
|---|---|---|
| Group A :combined phacoaspiration and angle surgery* Partial thickness scleral flap to access the canal of schlemm. * 2 side ports will be fashioned. * Trypan blue will be injected to aid visualization of the anterior capsule \& continuous curvilinear anterior capsulorhexis of approximately 5.0 mm diameter will be done. * The nucleus and cortex will be aspirated. * Posterior capsulrehxis and limited anterior vitrectomy will be done. * Corneal incisions will be sutured with 10-0 Nylon suture. * Using metal trabeculotomes to open thetrabecular meshwork after accessing the canal of schlemm. * Suturing of scleral flap with 10-0 Nylon suture. | Procedure or surgery | Group A: includes eyes for whom combined phacoaspiration & angle surgery will be done. |
| Group B : phacoaspiration only* 2 side ports will be fashioned. * Trypan blue will be injected to aid visualization of the anterior capsule \& continuous curvilinear anterior capsulorhexis of approximately 5.0 mm diameter will be done. * The nucleus and cortex will be aspirated. * Posterior capsulrehxis and limited anterior vitrectomy will be done. * Corneal incisions will be sutured with 10-0 Nylon suture. | Procedure or surgery | Group B : includes eyes with only phacoaspiration will be done |
Primary outcome
Intraocular pressure
Time frame: up to one year follow up
glaucoma
1 secondary outcome
rate of complications
Time frame: one year follow up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2022.
- Individual participant dataSharing planned: No. results of collected data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group A :combined phacoaspiration and angle surgery and Group B : phacoaspiration only in people with Pediatric Glaucoma, run by Mansoura University at 1 site in Egypt.
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 2 inclusion and 3 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 8 Sep 2022. 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 Egypt. 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?
Results are not available in the source record.
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?
Intraocular pressure (time frame: up to one year follow up). 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 8 Sep 2022.