Morphologic and Biometric Characteristics of Preexisting Posterior Capsule Defects in Congenital Cataracts During the First Year of Life

NCT ID: NCT03342794

Last Updated: 2017-11-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-01
• Study Completion Date: 2019-08-01

Brief Summary

Few descriptive studies have focused on the anatomical parameters in patients with preexisting PCDs. The characteristics of cataract morphology and anatomical parameters in these patients remained unclear, when compared with CC patients with intact posterior capsule. We conduct the current study to compare the cataract morphology and preoperative parameters, including central corneal thickness, axial length, anterior chamber depth, lens thickness, corneal diameter, keratometry，dialated pupil diameter and intraocular pressure, between CC patients with preexisting PCDs and those with intact posterior capsule, and to explore potential risk factors for preexisting PCDs.

Detailed Description

This retrospective study reviewed infants (≤1 years old) with CC who were undergoing cataract extraction without IOL implantation at the Eye Hospital of Wenzhou Medical University, Hangzhou, China. CC patients with preexisting PCDs were placed in Study group, while CC patients with intact posterior capsule were included as controls.

The preexisting PCD was diagnosed if signs of a sharply bordered defect or white dots on the posterior capsule and/or in the anterior vitreous were detected. The intraoperative diagnosis of preexisting PCD was confirmed when the signs were observed after uneventful aspiration of the lens cortex. Patients who were incooperative to complete the preoperative examinations were excluded.

All CC patients were divided into two groups according to integrity of posterior capsule. Patients with a confirmed preexisting PCD were placed into the PCD group. Others with intact posterior capsule were in the control group. The preoperative data including sex, age at surgery, laterality of disease, and accompanying ocular anomalies were collected.

For all the CC patients, the preoperative examinations were completed under sedation. Central corneal thickness was obtained by a handheld ultrasonic pachymeter (PachPen, Accutome, US). Axial length, anterior chamber depth, lens thickness and length of vitreous cavity were measured via an immersion A-scan (Axis nano, Quantel Medical, French). An experienced examiner repeated the measurement 10 times and the mean value was included. The keratometry values and intraocular pressure were gained by a handheld keratometer (HandyRef-K, NIDEK, Japan) and a handheld tonometer (Icare, Vantaa, Finland), respectively. Diameter of cornea and dilated pupil (dilated by tropicamide 0.5% and phenylephrine hydrochloride 0.5%) was measured just before surgery.

All surgeries were performed by the same surgeon (Y.E.Z.) under general anesthesia. Bimanual irrigation/aspiration and 2-port 23G anterior vitrectomy were performed. Three ophthalmologists reviewed all surgical recordings. The integrity of posterior capsule was masked to them. Morphological characteristics of cataracts were documented before surgery. After removing opaque cortex and/or nucleus, the configuration of preexisting PCDs was described.

Conditions

Congenital Cataract

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

preexisting posterior capsule defects

congenital cataracts with a preexisting posterior capsule defect

Group Type: OTHER

cataract surgery

Intervention Type: PROCEDURE

To diagnose the preexisting posterior capsule defects in congenital cataracts after the cataracts are removed by surgery and observe the characteristics

Interventions

cataract surgery

To diagnose the preexisting posterior capsule defects in congenital cataracts after the cataracts are removed by surgery and observe the characteristics

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• congenital cataract

Exclusion Criteria

• incooperative to complete the preoperative examinations

• Maximum Eligible Age: 1 Year
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wenzhou Medical University

OTHER

Sponsor Role: lead

Responsible Party

yin ying zhao

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Eye Hospital of Wenzhou Medical College

Wenzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Zhangliang Li, MD

Role: CONTACT

Phone: 86-571-88185666

Email: lizhangliang0328@126.com

Facility Contacts

zhao Yinying, PhD

Role: primary

Other Identifiers

PCD_HZ

Identifier Type: -

Identifier Source: org_study_id