NCT03016507

Brief Summary

The objective of this study is to evaluate the IOP variation before and 30 days after performing phacoemulsification through pneumatic tonometry, in addition to evaluating the factors possibly related to this variation.

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 all trials

Timeline
Completed

Started Jul 2015

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

July 1, 2015

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

January 6, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 10, 2017

Completed
Last Updated

January 10, 2017

Status Verified

January 1, 2017

Enrollment Period

1.5 years

First QC Date

January 6, 2017

Last Update Submit

January 6, 2017

Conditions

Intraocular PressureCataracts Senile

Keywords

intraocular pressurephacoemulsificationcataract

Outcome Measures

Primary Outcomes (1)

  • Intraocular Pressure Variation by Pneumatic Tonometer Before and After Phacoemulsification

    Six months

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

People with cataract and with good systemic health

You may qualify if:

  • older than 18 years
  • deep anterior chamber visualized by the slit lamp with open angle estimation using the Van Herick technique
  • IOP lower than 21 mmHg
  • without surgical intercurrences, submitted to phacoemulsification

You may not qualify if:

  • younger than 18 years
  • shallow anterior chamber visualized by slit lamp with estimation of narrow angle
  • preoperative surgical complications
  • IOP greater than 21 mmHg
  • contact lens wearers
  • eye surgeries and/or ocular diseases and/or systemic disorders.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rodrigo Egidio da Silva

Goiânia, Goiás, 74180-010, Brazil

Location

Related Publications (8)

  • Poley BJ, Lindstrom RL, Samuelson TW, Schulze R Jr. Intraocular pressure reduction after phacoemulsification with intraocular lens implantation in glaucomatous and nonglaucomatous eyes: evaluation of a causal relationship between the natural lens and open-angle glaucoma. J Cataract Refract Surg. 2009 Nov;35(11):1946-55. doi: 10.1016/j.jcrs.2009.05.061.

    PMID: 19878828BACKGROUND

  • Poley BJ, Lindstrom RL, Samuelson TW. Long-term effects of phacoemulsification with intraocular lens implantation in normotensive and ocular hypertensive eyes. J Cataract Refract Surg. 2008 May;34(5):735-42. doi: 10.1016/j.jcrs.2007.12.045.

    PMID: 18471626BACKGROUND

  • Slabaugh MA, Bojikian KD, Moore DB, Chen PP. The effect of phacoemulsification on intraocular pressure in medically controlled open-angle glaucoma patients. Am J Ophthalmol. 2014 Jan;157(1):26-31. doi: 10.1016/j.ajo.2013.08.023. Epub 2013 Oct 30.

    PMID: 24182743BACKGROUND

  • Damji KF, Konstas AG, Liebmann JM, Hodge WG, Ziakas NG, Giannikakis S, Mintsioulis G, Merkur A, Pan Y, Ritch R. Intraocular pressure following phacoemulsification in patients with and without exfoliation syndrome: a 2 year prospective study. Br J Ophthalmol. 2006 Aug;90(8):1014-8. doi: 10.1136/bjo.2006.091447. Epub 2006 May 3.

    PMID: 16672324BACKGROUND

  • Bigger JF, Becker B. Cataracts and primary open-angle glaucoma: the effect of uncomplicated cataract extraction on glaucoma control. Trans Am Acad Ophthalmol Otolaryngol. 1971 Mar-Apr;75(2):260-72. No abstract available.

    PMID: 4933971BACKGROUND

  • Yang HS, Lee J, Choi S. Ocular biometric parameters associated with intraocular pressure reduction after cataract surgery in normal eyes. Am J Ophthalmol. 2013 Jul;156(1):89-94.e1. doi: 10.1016/j.ajo.2013.02.003. Epub 2013 Apr 28.

    PMID: 23628350BACKGROUND

  • Vincent SJ, Vincent RA, Shields D, Lee GA. Comparison of intraocular pressure measurement between rebound, non-contact and Goldmann applanation tonometry in treated glaucoma patients. Clin Exp Ophthalmol. 2012 May-Jun;40(4):e163-70. doi: 10.1111/j.1442-9071.2011.02670.x. Epub 2011 Oct 20.

    PMID: 21883774BACKGROUND

  • Shingleton BJ, Pasternack JJ, Hung JW, O'Donoghue MW. Three and five year changes in intraocular pressures after clear corneal phacoemulsification in open angle glaucoma patients, glaucoma suspects, and normal patients. J Glaucoma. 2006 Dec;15(6):494-8. doi: 10.1097/01.ijg.0000212294.31411.92.

    PMID: 17106361BACKGROUND

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Study Design

Study Type
observational
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ophtalmologist

Study Record Dates

First Submitted

January 6, 2017

First Posted

January 10, 2017

Study Start

July 1, 2015

Primary Completion

January 1, 2017

Study Completion

January 1, 2017

Last Updated

January 10, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)