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Combined Phacoaspiration and Angle Surgery Versus Phacoaspiration in Pediatric Cataract

Sponsor
Mansoura University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05401760
Collaborator
(none)
30
Enrollment
2
Arms
9
Anticipated Duration (Months)

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Procedure: Group A :combined phacoaspiration and angle surgery
  • Procedure: Group B : phacoaspiration only
 N/A

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:

  1. 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.

  2. 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).

  1. 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:
  1. 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.

  1. 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:
  1. All patients will be discharged on:

  • Systemic &topical antibiotic eye drops.

  • Topical steroids.

  • Cycloplegic eye drops.

  • Combined antibiotic and steroid eye ointment.

  1. Topical Steroids & cycloplegic eye drops will be gradually withdrawn over a period of 3 months.

  2. The eyes will be carefully examined at each follow-up visit (1 week, 2 weeks 1months and 3 months).

  3. 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

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention 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 glaucomaInclusion 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)
Primary Purpose:
Treatment
Official Title:
Combined Phacoaspiration and Angle Surgery Versus Phacoaspiration in Pediatric Cataract
Anticipated Study Start Date :
May 30, 2022
Anticipated Primary Completion Date :
Nov 30, 2022
Anticipated Study Completion Date :
Mar 1, 2023

Arms and Interventions

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. 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: 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.
Active Comparator: Group B : includes eyes with only phacoaspiration will be done

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.

Procedure: 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.

Outcome Measures

Primary Outcome Measures

  1. Intraocular pressure [up to one year follow up]

    glaucoma

Secondary Outcome Measures

  1. rate of complications [one year follow up]

    hyphaema or intraocular inflammation

Eligibility Criteria

Criteria

Ages Eligible for Study:
1 Month to 24 Months
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Mansoura University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Dina abdelfattah, lecturer of ophthalmology Mansoura University, Mansoura University
ClinicalTrials.gov Identifier:
NCT05401760
Other Study ID Numbers:
  • R.22.05.1718
First Posted:
Jun 2, 2022
Last Update Posted:
Jun 2, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Cataract

Study Results

No Results Posted as of Jun 2, 2022