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CME With Different Fluidic Parameters

Primary Purpose

Cystoid Macular Edema Following Cataract Surgery

Status
Completed
Phase
Phase 4
Locations
India
Study Type
Interventional
Intervention
microcoaxial phacoemulsification
Sponsored by
Iladevi Cataract and IOL Research Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cystoid Macular Edema Following Cataract Surgery focused on measuring CME, OCT, Optical coherence tomography, macular thickness

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Raghudeep Eye Clinic

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Longitudinal U/S - low fluidic

Torsional U/S - low fluidic

Longitudinal U/S - high fluidic

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

macular thickness
macular thickness measured in 3 zones using the anterior segment OCT
central corneal thickness (CCT)
CCT will be measured on the ultrasound pachymeter by a single experienced observer
endothelial cell loss
Endothelial cell loss will be measured using a specular microscope in the central area by a single technician
anterior chamber inflammation
it will be assessed on the slit lamp examination by a single experienced observer using the Hogan's criteria
CORRECTED DISTANCE VISUAL ACUITY (CDVA)
visual acuity (VA) of 20/40 or worse was defined as "clinically significant"

Full Information

First Posted
June 28, 2011
Last Updated
June 5, 2012
Sponsor
Iladevi Cataract and IOL Research Center
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1. Study Identification

Unique Protocol Identification Number
NCT01385852
Brief Title
CME With Different Fluidic Parameters
Official Title
Impact of Different Fluidic Parameters on Development of Cystoid Macular Edema Following Phacoemulsification
Study Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
February 2011 (Actual)
Study Completion Date
August 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Iladevi Cataract and IOL Research Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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
Detailed Description
Several studies have shown the adverse impact of an increase in the IOP and IOP fluctuations that occur during anterior segment intervention on the posterior segment structures. In human volunteers with each incremental increase in IOP the systolic and diastolic flow velocities in the short posterior ciliary arteries decreased linearly. This implies that the normal healthy eye is not able to autoregulate to maintain posterior ciliary artery blood flow velocities in response to acute large elevations in IOP. Vascular insufficiency due to abnormal autoregulation has been proposed as a major factor in the development of glaucoma. 1 It has been postulated that IOP elevation during the LASIK procedure causes mechanical stress which may induce tangential stress on the posterior segment.2, 3 Some studies have reported that the increase in IOP damages the retinal ganglion cells causing visual field defects. Also sudden increases in IOP, although well tolerated may induce changes in the peripheral retina.4,5,6 Several reports propose the occurrence of macular hole, lacquer cracks and choroidal neovascular membranes following the LASIK procedure. 3 It has been observed that the rapidly fluctuating pressure variations may be detrimental, particularly in susceptible persons with compromised ocular blood flow. Rapid IOP changes across a 30-mm Hg range would be predicted to influence posterior segment blood vessels. In a previous study we compared the impact of using high fluid parameters versus low fluidic parameters on real-time IOP measured during phacoemulsification. We 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. We hypothesize that although transient, the increased IOP that occurs during phacoemulsification when using high parameters could cause mechanical stress on the eye. These higher fluid parameters during phacoemulsification can predispose the eye to increased macular thickness. To the best of our knowledge there are no published data on impact of IOP changes and fluctuation that are induced during cataract surgery on the macula. To investigate this further, we decided to study the impact of using high parameters (and thus, higher chamber instability) on macular thickness following surgery, in an otherwise uncomplicated surgery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystoid Macular Edema Following Cataract Surgery
Keywords
CME, OCT, Optical coherence tomography, macular thickness

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Longitudinal U/S - low fluidic
Arm Type
Active Comparator
Arm Description
ASPIRATION FLOW RATE - 25 CC/MIN, BOTTLE HEIGHT - 90 CMS, LONGITUDINAL ULTRASOUND
Arm Title
Torsional U/S - low fluidic
Arm Type
Active Comparator
Arm Description
ASPIRATION FLOW RATE - 25 CC/MIN, BOTTLE HEIGHT - 90 CMS, TORSIONAL ULTRASOUND
Arm Title
Longitudinal U/S - high fluidic
Arm Type
Active Comparator
Arm Description
ASPIRATION FLOW RATE - 40 CC/MIN, BOTTLE HEIGHT - 110 CMS, LONGITUDINAL ULTRASOUND
Intervention Type
Procedure
Intervention Name(s)
microcoaxial phacoemulsification
Other Intervention Name(s)
phacoemulsification, small incision cataract surgery
Intervention Description
conventional longitudinal ultrasound
Primary Outcome Measure Information:
Title
cystoid macular edema (CME)
Description
A > or = 30% increase in baseline central foveal thickness measaured by anterior segment OCT will be defined as having CME.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
macular thickness
Description
macular thickness measured in 3 zones using the anterior segment OCT
Time Frame
1, 3 months
Title
central corneal thickness (CCT)
Description
CCT will be measured on the ultrasound pachymeter by a single experienced observer
Time Frame
first post-operative day,
Title
endothelial cell loss
Description
Endothelial cell loss will be measured using a specular microscope in the central area by a single technician
Time Frame
6 months post-operative
Title
anterior chamber inflammation
Description
it will be assessed on the slit lamp examination by a single experienced observer using the Hogan's criteria
Time Frame
1 months
Title
CORRECTED DISTANCE VISUAL ACUITY (CDVA)
Description
visual acuity (VA) of 20/40 or worse was defined as "clinically significant"
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Uncomplicated, Age-related cataract. Nuclear sclerosis: upto grade 3 Age: 40-70 years Axial length: 21.5 mm to 24.5 mm Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ABHAY R VASAVADA, MS, FRCS
Organizational Affiliation
ILADEVI CATARACT AND RESEARCH CENTER
Official's Role
Principal Investigator
Facility Information:
Facility Name
Raghudeep Eye Clinic
City
Ahmedabad
State/Province
Gujarat
ZIP/Postal Code
380013
Country
India

12. IPD Sharing Statement

Citations:
PubMed Identifier
18536605
Citation
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.
Results Reference
result
PubMed Identifier
19958122
Citation
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.
Results Reference
result
PubMed Identifier
19403110
Citation
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.
Results Reference
result
PubMed Identifier
17540324
Citation
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.
Results Reference
result
PubMed Identifier
17275910
Citation
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.
Results Reference
result
PubMed Identifier
17453944
Citation
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.
Results Reference
result
PubMed Identifier
16751754
Citation
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.
Results Reference
result

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CME With Different Fluidic Parameters

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