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Prophylactic Peripheral Iridectomy Prevents Aphakic Angle-closure Glaucoma

Primary Purpose

Congenital Cataract, Aphakic Glaucoma

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
PPI group
cataract extraction
Sponsored by
Zhongshan Ophthalmic Center, Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Congenital Cataract focused on measuring congenital cataract, prophylactic peripheral iridectomy, aphakic angle-closure glaucoma, aphakic open-angle glaucoma, iris posterior synechia, visual axis opacity

Eligibility Criteria

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

Inclusion Criteria:

  1. patients less than 2 years old;
  2. patients performed with congenital cataract surgery with or without PPI;
  3. patients with routine follow-up at ZOC.

Exclusion Criteria:

  1. patients with IOP ≥21 mm Hg or with congenital glaucoma or with a family history of glaucoma;
  2. patients with keratopathy, retinopathy, ocular trauma, radiation therapy or intraocular surgery;
  3. patients associated with other congenital ocular anomalies, such as anterior segment dysgenesis, microcornea/microphthalmia, persistent fetal vasculature, lens dislocation and iridocoloboma;
  4. patients with systemic diseases, such as Down's syndrome, Lowe syndrome, Stickler syndrome, maternal rubella syndrome or trisomy 13.

Sites / Locations

  • State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University
  • Zhongshan Ophthalmic Center, Sun Yet-san University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

PPI group

historical control group

Arm Description

cataract extraction surgery with prophylactic peripheral iridectomy

cataract extraction surgery

Outcomes

Primary Outcome Measures

The rate of aphakic angle-closure glaucoma
Pupillary block with subsequent closure of the filtration angle is the cause of early aphakic angle-closure glaucoma (AACG), which usually happens in the early postoperative period, generally within the first 6 months. AACG presents with elevated IOP (repeatedly >25 mmHg), corneal edema, iris bombe, shallow anterior chamber, peripheral anterior synechia and angle closure.

Secondary Outcome Measures

The rate of iris posterior synechia
Postoperative uveal inflammation can result in iris posterior synechia (IPS), referring to the synechia between iris and capsule around pupil. IPS is graded according to the range of the synechia. Grade 0: no synechia; Grade I: <1 quadrant; Grade II: ≤2 quadrants and >1 quadrant ; Grade III: ≤3 quadrants and >2 quadrants; Grade IV: >3 quadrants.
The rate of visual axis opacity
visual axis opacification (VAO) refers to developing reopacification of the visual axis in the form of lens proliferation into the visual axis or pupillary membrane.

Full Information

First Posted
July 25, 2018
Last Updated
March 9, 2019
Sponsor
Zhongshan Ophthalmic Center, Sun Yat-sen University
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1. Study Identification

Unique Protocol Identification Number
NCT03610295
Brief Title
Prophylactic Peripheral Iridectomy Prevents Aphakic Angle-closure Glaucoma
Official Title
A Novel Prophylactic Peripheral Iridectomy Prevents Aphakic Angle-closure Glaucoma After Congenital Cataract Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
August 2, 2018 (Actual)
Primary Completion Date
March 5, 2019 (Actual)
Study Completion Date
March 5, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zhongshan Ophthalmic Center, Sun Yat-sen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a retrospective, nonrandomized comparative trial with historical control to investigate the safety and efficacy of a novel progressive grasping peripheral iridectomy (PGPI) surgical method in preventing aphakic angle-closure glaucoma (AACG) following congenital cataract surgery.
Detailed Description
Aphakic angle-closure glaucoma (AACG) following congenital cataract surgery is a common and serious complication which can be prevented by prophylactic peripheral iridectomy (PPI). However, it is difficult to perform routine PPI via scleral tunnel incision especially when the pupil is dilated. Here, the investigators designed a novel progressive grasping peripheral iridectomy (PGPI) surgical method which can ensure the accurate iridectomy position and minimize the complication. The aim of this study is to assess the safety and efficacy of the PGPI in preventing AACG following congenital cataract surgery. This is a retrospective, nonrandomized comparative trial with historical control. The congenital cataract patients performed with cataract extraction combined with PPI (PPI group) and the patients performed with cataract extraction alone and leaving the iris intact (historical control group) were enrolled and a retrospective medical chart review was conducted. The IOP, anterior chamber depth, corneal clarity, patency of peripheral iridectomy opening, and the rate of AACG, iris posterior synechia (IPS) and visual axis opacity (VAO) were compared between two groups.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congenital Cataract, Aphakic Glaucoma
Keywords
congenital cataract, prophylactic peripheral iridectomy, aphakic angle-closure glaucoma, aphakic open-angle glaucoma, iris posterior synechia, visual axis opacity

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Retrospective,consecutive,nonrandomized comparative trial with historical control
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
87 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PPI group
Arm Type
Experimental
Arm Description
cataract extraction surgery with prophylactic peripheral iridectomy
Arm Title
historical control group
Arm Type
Active Comparator
Arm Description
cataract extraction surgery
Intervention Type
Procedure
Intervention Name(s)
PPI group
Intervention Description
The patients underwent cataract extraction, posterior capsulotomy, anterior vitrectomy combined with prophylactic peripheral iridectomy.
Intervention Type
Procedure
Intervention Name(s)
cataract extraction
Intervention Description
The patients underwent cataract extraction, posterior capsulotomy combined with anterior vitrectomy and leave the iris intact.
Primary Outcome Measure Information:
Title
The rate of aphakic angle-closure glaucoma
Description
Pupillary block with subsequent closure of the filtration angle is the cause of early aphakic angle-closure glaucoma (AACG), which usually happens in the early postoperative period, generally within the first 6 months. AACG presents with elevated IOP (repeatedly >25 mmHg), corneal edema, iris bombe, shallow anterior chamber, peripheral anterior synechia and angle closure.
Time Frame
18-49 months
Secondary Outcome Measure Information:
Title
The rate of iris posterior synechia
Description
Postoperative uveal inflammation can result in iris posterior synechia (IPS), referring to the synechia between iris and capsule around pupil. IPS is graded according to the range of the synechia. Grade 0: no synechia; Grade I: <1 quadrant; Grade II: ≤2 quadrants and >1 quadrant ; Grade III: ≤3 quadrants and >2 quadrants; Grade IV: >3 quadrants.
Time Frame
18-49 months
Title
The rate of visual axis opacity
Description
visual axis opacification (VAO) refers to developing reopacification of the visual axis in the form of lens proliferation into the visual axis or pupillary membrane.
Time Frame
18-49 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Months
Maximum Age & Unit of Time
24 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patients less than 2 years old; patients performed with congenital cataract surgery with or without PPI; patients with routine follow-up at ZOC. Exclusion Criteria: patients with IOP ≥21 mm Hg or with congenital glaucoma or with a family history of glaucoma; patients with keratopathy, retinopathy, ocular trauma, radiation therapy or intraocular surgery; patients associated with other congenital ocular anomalies, such as anterior segment dysgenesis, microcornea/microphthalmia, persistent fetal vasculature, lens dislocation and iridocoloboma; patients with systemic diseases, such as Down's syndrome, Lowe syndrome, Stickler syndrome, maternal rubella syndrome or trisomy 13.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yizhi Liu, PhD
Organizational Affiliation
Zhongshan Ophthalmic Center, Sun Yat-sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Facility Name
Zhongshan Ophthalmic Center, Sun Yet-san University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

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Prophylactic Peripheral Iridectomy Prevents Aphakic Angle-closure Glaucoma

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