NCT03262285

Brief Summary

the investigators will compare between the endothelial cell loss after phacoemulsification and extracapsular cataract extraction in management of senile cataract

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2018

Typical duration for all trials

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

First Submitted

Initial submission to the registry

August 23, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 25, 2017

Completed
10 months until next milestone

Study Start

First participant enrolled

July 1, 2018

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2021

Completed
Last Updated

January 27, 2021

Status Verified

May 1, 2020

Enrollment Period

2.5 years

First QC Date

August 23, 2017

Last Update Submit

January 25, 2021

Conditions

Senile Cataract

Outcome Measures

Primary Outcomes (1)

  • percentage of endothelial cell loss

    specular microscopy will be done to measure the endothelial cell count before and after the intervention to measure the percentage of loss

    5 minutes

Secondary Outcomes (1)

  • changes in shape of endothelial cell

    5 minutes

Study Arms (2)

phacoemulsification

patients undergoing phacoemulsification surgery for senile cataract

Procedure: phacoemulsification

extracapsular cataract extraction

patients undergoing extracapsular cataract extraction surgery for senile cataract

Procedure: extracapsular cataract extraction

Interventions

phacoemulsificationPROCEDURE

removal of cataract using ultrasound waves

phacoemulsification
extracapsular cataract extractionPROCEDURE

removal of cataract using surgical corneal incision

extracapsular cataract extraction

Eligibility Criteria

Age60 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with senile cataract

You may qualify if:

  • Cases of senile cataract of both sexes will be included in this study

You may not qualify if:

  • Corneal endothelial pathologies such as Fuch's dystrophy
  • Complicated cataract
  • Cataract with history of trauma
  • Coexisting eye pathology

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut university

Asyut, Egypt

Location

Related Publications (8)

  • Lundstrom M, Goh PP, Henry Y, Salowi MA, Barry P, Manning S, Rosen P, Stenevi U. The changing pattern of cataract surgery indications: a 5-year study of 2 cataract surgery databases. Ophthalmology. 2015 Jan;122(1):31-8. doi: 10.1016/j.ophtha.2014.07.047. Epub 2014 Sep 16.

    PMID: 25234011BACKGROUND

  • Bourne RR, Stevens GA, White RA, Smith JL, Flaxman SR, Price H, Jonas JB, Keeffe J, Leasher J, Naidoo K, Pesudovs K, Resnikoff S, Taylor HR; Vision Loss Expert Group. Causes of vision loss worldwide, 1990-2010: a systematic analysis. Lancet Glob Health. 2013 Dec;1(6):e339-49. doi: 10.1016/S2214-109X(13)70113-X. Epub 2013 Nov 11.

    PMID: 25104599BACKGROUND

  • Resnikoff S, Pascolini D, Etya'ale D, Kocur I, Pararajasegaram R, Pokharel GP, Mariotti SP. Global data on visual impairment in the year 2002. Bull World Health Organ. 2004 Nov;82(11):844-51. Epub 2004 Dec 14.

    PMID: 15640920BACKGROUND

  • Wang W, Yan W, Muller A, He M. A Global View on Output and Outcomes of Cataract Surgery With National Indices of Socioeconomic Development. Invest Ophthalmol Vis Sci. 2017 Jul 1;58(9):3669-3676. doi: 10.1167/iovs.17-21489.

    PMID: 28728174BACKGROUND

  • Gogate PM, Kulkarni SR, Krishnaiah S, Deshpande RD, Joshi SA, Palimkar A, Deshpande MD. Safety and efficacy of phacoemulsification compared with manual small-incision cataract surgery by a randomized controlled clinical trial: six-week results. Ophthalmology. 2005 May;112(5):869-74. doi: 10.1016/j.ophtha.2004.11.055.

    PMID: 15878068BACKGROUND

  • Bourne WM, Nelson LR, Hodge DO. Central corneal endothelial cell changes over a ten-year period. Invest Ophthalmol Vis Sci. 1997 Mar;38(3):779-82.

    PMID: 9071233BACKGROUND

  • Bourne RR, Minassian DC, Dart JK, Rosen P, Kaushal S, Wingate N. Effect of cataract surgery on the corneal endothelium: modern phacoemulsification compared with extracapsular cataract surgery. Ophthalmology. 2004 Apr;111(4):679-85. doi: 10.1016/j.ophtha.2003.07.015.

    PMID: 15051198BACKGROUND

  • Trnavec B, Cuvala J, Cernak A, Vodrazkova E. [Comparison of corneal endothelial cells after ECCE and phacoemulsification of the lens]. Cesk Slov Oftalmol. 1997 Aug;53(4):240-3. Slovak.

    PMID: 9377317BACKGROUND

MeSH Terms

Interventions

Phacoemulsification

Intervention Hierarchy (Ancestors)

Cataract ExtractionRefractive Surgical ProceduresOphthalmologic Surgical ProceduresSurgical Procedures, OperativeUltrasonic Surgical Procedures

Study Officials

  • Ali Ryad, professor

    Assiut University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
resident

Study Record Dates

First Submitted

August 23, 2017

First Posted

August 25, 2017

Study Start

July 1, 2018

Primary Completion

January 1, 2021

Study Completion

January 15, 2021

Last Updated

January 27, 2021

Record last verified: 2020-05

Locations

EG(1)