- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05401760
Combined Phacoaspiration and Angle Surgery Versus Phacoaspiration in Pediatric Cataract
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Dakahlia
-
Mansoura, Dakahlia, Egypt, 35100
- Dina Abd Elfattah
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion criteria:
- 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
Exclusion criteria:
- Acquired cataracts secondary to trauma or uveitis.
- Aged more than two years.
- Associated corneal opacities.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Group A: includes eyes for whom combined phacoaspiration & angle surgery will be done.
Group A: for whom combined phacoaspiration & angle surgery trabeculotomy will be done.
|
|
ACTIVE_COMPARATOR: Group B : includes eyes with only phacoaspiration will be done
Group B: for whom phacoaspiration only will be done.
|
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Intraocular pressure
Time Frame: up to one year follow up
|
glaucoma
|
up to one year follow up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
rate of complications
Time Frame: one year follow up
|
hyphaema or intraocular inflammation
|
one year follow up
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R.22.05.1718
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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