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Combined Phacoaspiration and Angle Surgery Versus Phacoaspiration in Pediatric Cataract

Primary Purpose

Pediatric Glaucoma

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Group A :combined phacoaspiration and angle surgery
Group B : phacoaspiration only
Sponsored by
Mansoura University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pediatric Glaucoma

Eligibility Criteria

1 Month - 24 Months (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Dina Abd Elfattah

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Group A: includes eyes for whom combined phacoaspiration & angle surgery will be done.

Group B : includes eyes with only phacoaspiration will be done

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Intraocular pressure
glaucoma

Secondary Outcome Measures

rate of complications
hyphaema or intraocular inflammation

Full Information

First Posted
May 16, 2022
Last Updated
September 3, 2022
Sponsor
Mansoura University
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1. Study Identification

Unique Protocol Identification Number
NCT05401760
Brief Title
Combined Phacoaspiration and Angle Surgery Versus Phacoaspiration in Pediatric Cataract
Official Title
Combined Phacoaspiration and Angle Surgery Versus Phacoaspiration in Pediatric Cataract
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
May 30, 2022 (Actual)
Primary Completion Date
November 30, 2022 (Anticipated)
Study Completion Date
March 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mansoura University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pediatric Glaucoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Inclusion criteria: 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. Patient with pediatric cataract with other eye had post cataract surgery glaucoma
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A: includes eyes for whom combined phacoaspiration & angle surgery will be done.
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Group B : includes eyes with only phacoaspiration will be done
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Group A :combined phacoaspiration and angle surgery
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Group B : phacoaspiration only
Intervention Description
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.
Primary Outcome Measure Information:
Title
Intraocular pressure
Description
glaucoma
Time Frame
up to one year follow up
Secondary Outcome Measure Information:
Title
rate of complications
Description
hyphaema or intraocular inflammation
Time Frame
one year follow up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
24 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Dina Abd Elfattah
City
Mansoura
State/Province
Dakahlia
ZIP/Postal Code
35100
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
results of collected data

Learn more about this trial

Combined Phacoaspiration and Angle Surgery Versus Phacoaspiration in Pediatric Cataract

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