NCT01385852

Brief Summary

Understanding and modulating fluid parameters is an important, but often overlooked aspect of phacoemulsification. In a previous study we compared the impact of using high fluid parameters versus low fluidic parameters on real-time IOP measured during phacoemulsification. The investigators found that using high parameters resulted in a higher absolute rise in IOP as well as higher fluctuations in the IOP when compared to low parameters. Clinically these higher fluctuations in IOP would translate in a higher chamber instability. Based on the results of this study, the investigators decided to take it further and study the impact of using high parameters (and thus, higher chamber instability) on macular edema and thickness following surgery, in an otherwise uncomplicated surgery. Higher fluid parameters during phacoemulsification predisposes the eye to increased macular thickness

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started May 2010

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

May 1, 2010

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 28, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 30, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

June 6, 2012

Status Verified

June 1, 2012

Enrollment Period

9 months

First QC Date

June 28, 2011

Last Update Submit

June 5, 2012

Conditions

Cystoid Macular Edema Following Cataract Surgery

Keywords

CMEOCTOptical coherence tomographymacular thickness

Outcome Measures

Primary Outcomes (1)

  • cystoid macular edema (CME)

    A \> or = 30% increase in baseline central foveal thickness measaured by anterior segment OCT will be defined as having CME.

    3 months

Secondary Outcomes (5)

  • macular thickness

    1, 3 months

  • central corneal thickness (CCT)

    first post-operative day,

  • endothelial cell loss

    6 months post-operative

  • anterior chamber inflammation

    1 months

  • CORRECTED DISTANCE VISUAL ACUITY (CDVA)

    3 months

Study Arms (3)

Longitudinal U/S - low fluidic

ACTIVE COMPARATOR

ASPIRATION FLOW RATE - 25 CC/MIN, BOTTLE HEIGHT - 90 CMS, LONGITUDINAL ULTRASOUND

Procedure: microcoaxial phacoemulsification

Torsional U/S - low fluidic

ACTIVE COMPARATOR

ASPIRATION FLOW RATE - 25 CC/MIN, BOTTLE HEIGHT - 90 CMS, TORSIONAL ULTRASOUND

Procedure: microcoaxial phacoemulsification

Longitudinal U/S - high fluidic

ACTIVE COMPARATOR

ASPIRATION FLOW RATE - 40 CC/MIN, BOTTLE HEIGHT - 110 CMS, LONGITUDINAL ULTRASOUND

Procedure: microcoaxial phacoemulsification

Interventions

microcoaxial phacoemulsificationPROCEDURE

conventional longitudinal ultrasound

Also known as: phacoemulsification, small incision cataract surgery
Longitudinal U/S - high fluidicLongitudinal U/S - low fluidicTorsional U/S - low fluidic

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Uncomplicated, Age-related cataract.
  • Nuclear sclerosis: upto grade 3
  • Age: 40-70 years
  • Axial length: 21.5 mm to 24.5 mm

You may not qualify if:

  • Diabetes mellitus
  • Co-existing ocular disease- uveitis, glaucoma, PEX
  • Pre-existing macular pathology (eg.ARMD)
  • Previously operated eyes
  • Under treatment with Topical or systemic steroids / NSAID's
  • Intraoperative complications- PCR, Descemet's detachment, uveal trauma
  • Post operative complications - severe inflammation (\>grade 3), rise in IOP

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Raghudeep Eye Clinic

Ahmedabad, Gujarat, 380013, India

Location

Related Publications (7)

  • Kim SJ, Belair ML, Bressler NM, Dunn JP, Thorne JE, Kedhar SR, Jabs DA. A method of reporting macular edema after cataract surgery using optical coherence tomography. Retina. 2008 Jun;28(6):870-6. doi: 10.1097/IAE.0b013e318169d04e.

    PMID: 18536605RESULT

  • Cagini C, Fiore T, Iaccheri B, Piccinelli F, Ricci MA, Fruttini D. Macular thickness measured by optical coherence tomography in a healthy population before and after uncomplicated cataract phacoemulsification surgery. Curr Eye Res. 2009 Dec;34(12):1036-41. doi: 10.3109/02713680903288937.

    PMID: 19958122RESULT

  • Belair ML, Kim SJ, Thorne JE, Dunn JP, Kedhar SR, Brown DM, Jabs DA. Incidence of cystoid macular edema after cataract surgery in patients with and without uveitis using optical coherence tomography. Am J Ophthalmol. 2009 Jul;148(1):128-35.e2. doi: 10.1016/j.ajo.2009.02.029. Epub 2009 Apr 29.

    PMID: 19403110RESULT

  • Lee YC, Chung FL, Chen CC. Intraocular pressure and foveal thickness after phacoemulsification. Am J Ophthalmol. 2007 Aug;144(2):203-208. doi: 10.1016/j.ajo.2007.04.020. Epub 2007 May 30.

    PMID: 17540324RESULT

  • Kim SJ, Equi R, Bressler NM. Analysis of macular edema after cataract surgery in patients with diabetes using optical coherence tomography. Ophthalmology. 2007 May;114(5):881-9. doi: 10.1016/j.ophtha.2006.08.053. Epub 2007 Feb 1.

    PMID: 17275910RESULT

  • Perente I, Utine CA, Ozturker C, Cakir M, Kaya V, Eren H, Kapran Z, Yilmaz OF. Evaluation of macular changes after uncomplicated phacoemulsification surgery by optical coherence tomography. Curr Eye Res. 2007 Mar;32(3):241-7. doi: 10.1080/02713680601160610.

    PMID: 17453944RESULT

  • Biro Z, Balla Z, Kovacs B. Change of foveal and perifoveal thickness measured by OCT after phacoemulsification and IOL implantation. Eye (Lond). 2008 Jan;22(1):8-12. doi: 10.1038/sj.eye.6702460. Epub 2006 Jun 2.

    PMID: 16751754RESULT

MeSH Terms

Interventions

Phacoemulsification

Intervention Hierarchy (Ancestors)

Cataract ExtractionRefractive Surgical ProceduresOphthalmologic Surgical ProceduresSurgical Procedures, OperativeUltrasonic Surgical Procedures

Study Officials

  • ABHAY R VASAVADA, MS, FRCS

    ILADEVI CATARACT AND RESEARCH CENTER

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

June 28, 2011

First Posted

June 30, 2011

Study Start

May 1, 2010

Primary Completion

February 1, 2011

Study Completion

August 1, 2011

Last Updated

June 6, 2012

Record last verified: 2012-06

Locations

IN(1)