NCT04931277

Brief Summary

This study aims to assess the short-term results of primary phacoemulsification and secondary posterior chamber intraocular lens (PCIOL) implantation in patients with uveitis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2021

Shorter than P25 for not_applicable

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

February 8, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2021

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2021

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

June 12, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 18, 2021

Completed
Last Updated

June 23, 2021

Status Verified

June 1, 2021

Enrollment Period

3 months

First QC Date

June 12, 2021

Last Update Submit

June 18, 2021

Conditions

Outcome of Stepped Cataract Surgery in Uveitis

Outcome Measures

Primary Outcomes (1)

  • Visulal acuity

    overall improvement in vision using LogMAR

    6 months

Secondary Outcomes (1)

  • Intraocular inflammation

    6 months

Study Arms (1)

stepped cataract surgery

OTHER
Procedure: cataract surgery

Interventions

cataract surgeryPROCEDURE

stepped surgery in the form of primary phacoemulsification and secondary posterior chamber intraocular lens (PCIOL) implantation in patients with uveitis.

stepped cataract surgery

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • the study will include any uveitic patients below 45 years old with complicated cataract and their best corrected visual acuity (BCVA) not better than 6/36 nor worse than hand movement

You may not qualify if:

  • the study will not include those with visual acuity more than 6/36 or patients with active uveitis or with posterior segment pathology discovered by ultrasonography that may affect to a lager extent the visual prognosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mansoura university

Al Mansurah, Dakahlyia, 35516, Egypt

Location

MeSH Terms

Interventions

Cataract Extraction

Intervention Hierarchy (Ancestors)

Refractive Surgical ProceduresOphthalmologic Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Amgad El Nokrashy, MD

    Mansoura University

    PRINCIPAL INVESTIGATOR

  • Dina Abd El Fattah, MD

    Mansoura University

    STUDY CHAIR

  • Rania Bassiouny, MD

    Mansoura University

    STUDY CHAIR

  • Shreen Gaafar, MD

    Mansoura University

    STUDY CHAIR

  • Waleed Gaafar, MD

    Mansoura University

    STUDY DIRECTOR

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
Lecturer of Ophthalmology

Study Record Dates

First Submitted

June 12, 2021

First Posted

June 18, 2021

Study Start

February 8, 2021

Primary Completion

May 15, 2021

Study Completion

May 30, 2021

Last Updated

June 23, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

results

Locations

EG(1)