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

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.

Study Overview

• Status: Unknown
• Conditions: Congenital Cataract
• Intervention / Treatment: Procedure: cataract surgery

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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Wenzhou, Zhejiang, China, 325027
      • Recruiting
      • Eye Hospital of Wenzhou Medical College
      • Contact: zhao Yinying, PhD; Phone Number: 13957763247; Email: ginger146@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 1 year (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• congenital cataract

Exclusion Criteria:

• incooperative to complete the preoperative examinations

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: preexisting posterior capsule defects; congenital cataracts with a preexisting posterior capsule defect	Procedure: cataract surgery; To diagnose the preexisting posterior capsule defects in congenital cataracts after the cataracts are removed by surgery and observe the characteristics

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
lens thickness measured by A-scan ultrasonography	lens thickness in congenital cataracts with either preexisting posterior capsule defects or intact posterior capsule will be measured by A-scan and compared.	6 months

Collaborators and Investigators

• Sponsor: Wenzhou Medical University

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2017
• Primary Completion (Anticipated): October 1, 2018
• Study Completion (Anticipated): August 1, 2019

Study Registration Dates

• First Submitted: November 6, 2017
• First Submitted That Met QC Criteria: November 9, 2017
• First Posted (Actual): November 17, 2017

Study Record Updates

• Last Update Posted (Actual): November 17, 2017
• Last Update Submitted That Met QC Criteria: November 9, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: PCD_HZ

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No