NCT04007965

Brief Summary

ABSTRACT PURPOSE: To evaluate a new technique of posterior capsulorhexis using air support to treat primary posterior capsular opacification (PCO) during cataract extraction surgery or to prevent post-operative PCO. SETTING: 1-Ophthalmology department, Faculty of medicine, Minia University, El-Minia, Egypt. 2- Security Forces Hospital, Ophthalmology Department, Riyadh, Kingdom of Saudi Arabia. DESIGN: Prospective, randomized case-control comparative study. Methods: 100 eyes of 100 patients with a mean age of 63.3 years with dens cataract. Fifty of them ( group 1) with primary PCO (discovered during the operations) and fifty (group 2) with clear posterior capsule. All cases undergone phacoemulsification, posterior capsulorhexis using the air to support the posterior capsule and separate it from the vitreous (the novel technique will be discussed later). Then IOL implantations wear done in the bag between the anterior and posterior capsular rim. Each patient was evaluated for the following:- visual acuity (UCVA and BCVA), intraocular pressure, intra ocular lens stability, visual axis opacification and posterior segment complications as retinal break, retinal detachment or cystoid macular oedema.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2017

Typical duration 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

January 1, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2018

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 25, 2019

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

June 29, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 5, 2019

Completed
Last Updated

July 5, 2019

Status Verified

July 1, 2019

Enrollment Period

1.1 years

First QC Date

June 29, 2019

Last Update Submit

July 2, 2019

Conditions

Posterior Capsule Opacification

Keywords

PCO

Outcome Measures

Primary Outcomes (4)

  • Visual acuity measured using snellen chart projector

    visual acuity (UCVA and BCVA) measured in decimal values

    one year

  • IOP measured in numerical values

    Intra-ocular pressure measured by Tono pen

    one year

  • IOL stability

    Intraocular Lens stability seen by slit lamb examination

    one year

  • Visual Axis Opacification

    Visual Axis Opacification seen by slit lamb examination

    0ne year

Secondary Outcomes (1)

  • posterior segment complications

    18 months

Study Arms (2)

Opacified posterior capsule

EXPERIMENTAL

PCO

Procedure: Pneumatic Posterior Capsulorhexis

Clear posterior capsule

ACTIVE COMPARATOR

CPC

Procedure: Pneumatic Posterior Capsulorhexis

Interventions

Pneumatic Posterior CapsulorhexisPROCEDURE

Pneumatic Posterior Capsulorhexis using air dose 0.1 ml and Healon dose 0.5 -1.0 ml.

Clear posterior capsuleOpacified posterior capsule

Eligibility Criteria

Age50 Years - 73 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Dense mature cataract without any local or systemic causes for the cataract.

You may not qualify if:

  • Any patients did not complete the follow up visits
  • younger patients and children

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Security forces hospital

Riyadh, Central, 11481-3643, Saudi Arabia

Location

Related Publications (2)

  • Walker TD. Pharmacological attempts to reduce posterior capsule opacification after cataract surgery--a review. Clin Exp Ophthalmol. 2008 Dec;36(9):883-90. doi: 10.1111/j.1442-9071.2009.01921.x.

    PMID: 19278485BACKGROUND

  • Eid AM, Abd-Elhamid Mehany Elwan S, Sabry AM, Moharram HM, Bakhsh AM. Novel Technique of Pneumatic Posterior Capsulorhexis for Treatment and Prevention of Posterior Capsular Opacification. J Ophthalmol. 2019 Dec 21;2019:3174709. doi: 10.1155/2019/3174709. eCollection 2019.

    PMID: 31949950DERIVED

Study Officials

  • Ahmed M Eid, MD

    Minia University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor of ophthalmology

Study Record Dates

First Submitted

June 29, 2019

First Posted

July 5, 2019

Study Start

January 1, 2017

Primary Completion

January 31, 2018

Study Completion

June 25, 2019

Last Updated

July 5, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations

SA(1)