NCT04220138

Brief Summary

With a poor red reflex, it is difficult to see the anterior capsule and continuous curvilinear capsulorhexis (CCC) margin, sometimes resulting in decentered CCC or radial tearing of the anterior capsule. In addition, other complications, such as rupture of the posterior capsule, dropping of the lens nucleus, or zonular dialysis, can occur during phacoemulsification because of poor visualization of the posterior capsule. These complications also increase the time of surgery and may affect the results of the vitrectomy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

January 3, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 7, 2020

Completed
Last Updated

January 9, 2020

Status Verified

January 1, 2020

Enrollment Period

6 months

First QC Date

January 3, 2020

Last Update Submit

January 6, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • number of patients with completion of the capsulorhexis and in-the-bag implantation of an intraocular lens

    number of patients with completion of the capsulorhexis and in-the-bag implantation of an intraocular lens

    intraoperative

Study Arms (1)

cataract patients with poor red reflex

OTHER

included cataract patients with poor red reflex

Procedure: Anterior chamber illumination in cataract surgery

Interventions

This will be a prospective interventional case series, patients with cataract and poor red reflex will undergo phacoemulsification assisted by anterior chamber illumination to overcome the problem of poor red reflex.

cataract patients with poor red reflex

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • cataract with poor red reflex

You may not qualify if:

  • Eyes that had previous intraocular surgery or trauma were excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alexandria university

Alexandria, Egypt

Location

MeSH Terms

Interventions

Cataract Extraction

Intervention Hierarchy (Ancestors)

Refractive Surgical ProceduresOphthalmologic Surgical ProceduresSurgical Procedures, Operative

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

January 3, 2020

First Posted

January 7, 2020

Study Start

January 1, 2019

Primary Completion

July 1, 2019

Study Completion

January 1, 2020

Last Updated

January 9, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will share

data of the patients are available to other researchers upon request

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
after publishing

Locations