Trials Sponsors Conditions Drugs Pricing

Conditions

Keywords

congenital cataractprophylactic peripheral iridectomyaphakic angle-closure glaucomaaphakic open-angle glaucomairis posterior synechiavisual axis opacity

Outcome Measures

Primary Outcomes (1)

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.
18-49 months

Secondary Outcomes (2)

The rate of iris posterior synechia
18-49 months
The rate of visual axis opacity
18-49 months

Study Arms (2)

PPI group

EXPERIMENTAL

cataract extraction surgery with prophylactic peripheral iridectomy

Procedure: PPI group

historical control group

ACTIVE COMPARATOR

cataract extraction surgery

Procedure: cataract extraction

Interventions

PPI groupProcedure

The patients underwent cataract extraction, posterior capsulotomy, anterior vitrectomy combined with prophylactic peripheral iridectomy.

PPI group

cataract extractionProcedure

The patients underwent cataract extraction, posterior capsulotomy combined with anterior vitrectomy and leave the iris intact.

historical control group

Eligibility Criteria

Age2 Months - 24 Months

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17)

You may qualify if:

patients less than 2 years old;
patients performed with congenital cataract surgery with or without PPI;

Sponsors & Collaborators

Zhongshan Ophthalmic Center, Sun Yat-sen University
Otherlead

Study Sites (2)

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

Guangzhou, Guangdong, 510060, China

Zhongshan Ophthalmic Center, Sun Yet-san University

Guangzhou, Guangdong, 510060, China

MeSH Terms

Interventions

Cataract Extraction

Intervention Hierarchy (Ancestors)

Refractive Surgical ProceduresOphthalmologic Surgical ProceduresSurgical Procedures, Operative

Study Officials

Yizhi Liu, PhD
Zhongshan Ophthalmic Center, Sun Yat-sen University
PRINCIPAL INVESTIGATOR

Enrollment

87 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: NON RANDOMIZED
Masking: NONE
Purpose: PREVENTION
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Clinical Professor,director of Zhongshan Ophthalmic Center

Study Record Dates

First Submitted

July 25, 2018

First Posted

August 1, 2018

Study Start

August 2, 2018

Prophylactic Peripheral Iridectomy Prevents Aphakic Angle-closure Glaucoma

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (2)

PPI group

historical control group

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (2)

PPI group

historical control group

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations