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CTRI Number  CTRI/2018/04/012954 [Registered on: 03/04/2018] Trial Registered Retrospectively
Last Modified On: 06/07/2021
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   PROSPECTIVE 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   This study is to assess the pre and post surgery complications of phaco surgery. 
Scientific Title of Study   Intra-operative challenges and post-operative follow-up of phacoemulsification in eyes with pseudoexfoliatin. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
12/2014  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Rohith R 
Designation  Primary DNB 
Affiliation  GIRIDHAR EYE INSTITUTE 
Address  PONNETH TEMPLE ROAD KADAVANTHRA COCHIN 682020

Ernakulam
KERALA
682020
India 
Phone  04844170000  
Fax  04844000584  
Email  drrrohith834@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Rohith R 
Designation  Primary DNB 
Affiliation  GIRIDHAR EYE INSTITUTE 
Address  PONNETH TEMPLE ROAD KADAVANTHRA COCHIN 682020

Ernakulam
KERALA
682020
India 
Phone  04844170000  
Fax  04844000584  
Email  drrrohith834@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Saikumar S J 
Designation  Head Cataract and Glaucoma 
Affiliation  GIRIDHAR EYE INSTITUTE 
Address  PONNETH TEMPLE ROAD KADAVANTHRA COCHIN 682020

Ernakulam
KERALA
682020
India 
Phone  9847040840  
Fax  04844000584  
Email  saikumarsj@yahoo.com  
 
Source of Monetary or Material Support  
Giridhar Eye Institute Ponneth Temple Road Kadavanthra Cochin 682020 
 
Primary Sponsor  
Name  Giridhar Eye Institute 
Address  Ponneth Temple Road Kadavanthra Cochin 682020 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Rohith R  Giridhar Eye Institute  Ponneth Temple Road Kadavanthra Cochin 682 020
Ernakulam
KERALA 
04844170000
04844000584
drrrohith834@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
GIRIDHAR EYE INSTITUTE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  85.00 Year(s)
Gender  Both 
Details  Patients with pseudoexfoliation advised for phacoemulsification surgery. 
 
ExclusionCriteria 
Details  (a) previous vitreo-retinal surgery
(b) previous history of trauma to eyes
(c) other causes of zonular weakness except that due to pseudoexfoliation 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To study the intra operative complications and postoperative outcome of phacoemulsification in patients with pseudoexfoliation.  12 months 
 
Secondary Outcome  
Outcome  TimePoints 
The patients will be followed up for one year after phaco surgery for any evidence of pseudoexfoliation.  12 Months 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/01/2014 
Date of Study Completion (India) 09/12/2014 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

INTRODUCTION

Pseudoexfoliation syndrome is a systemic disease with primarily ocular manifestations characterized by deposition of a whitish-gray protein on the lens, iris, ciliary epithelium, corneal endothelium and trabecular meshwork. studies have revealed that the lens epithelium, trabecular meshwork, iris, ciliary processes, conjunctiva and periocular tissue are its source. This material is insoluble and floats in the aqueous humor, from where it is filtered and deposited in the trabecular meshwork. Meanwhile local production of the proteinaceous material by the trabecular endothelial cells continues. All  these materials  accumulates in the trabecular spaces and focally collapses Schlemm’s canal. This decreases aqueous humor outflow and increases IOP.

 The signs of pseudoexfoliation syndrome can be identified on slit-lamp examination. Clinical examination using biomicroscopy has 85 percent sensitivity and 100 percent specificity. An easily recognizable sign of pseudoexfoliation is white, flaky material on the pupillary border of the iris or on the anterior surface of the lens. The lens frequently demonstrates a “three-ring sign” on the anterior lens capsule, which consists of a central zone of visible exfoliation material measuring 1 to 3 millimeters in diameter, combined with a middle clear zone and a peripheral cloudy ring. . The peripheral cloudy ring of the lens is usually only visible upon dilation.  The central zone is usually well demarcated and can have curled edges. The middle clear zone is thought to be created by the posterior surface of the iris rubbing off the pseudoexfoliative material from the lens. This also results in a loss of iris pigment leading to transillumination defects.

 More than 20 percent of patients with pseudoexfoliation syndrome have associated narrow angles; therefore, the anterior chamber depth of these patients should be assessed before dilation in order to avoid precipitating acute angle-closure glaucoma. The pigment granules can often be seen accumulating in the trabecular meshwork Gonioscopy reveals pigment deposition on the trabecular meshwork, usually more marked inferiorly, along with pigment around Schwalbe’s line. Pseudoexfoliation material has also been identified on the iris surface, corneal endothelium and zonules.

Poor pupillary  dilation is a subtle finding that is frequently observed in patients with pseudoexfoliation.It is believed to be due to iris dilator muscle atrophy and this can complicate cataract surgery. Such eyes also have phakodonesis,zonular dehiscence,capsule tear,vitreous loss and nucleous drop which poses intraoperative and postoperative challenges for cataract surgeons. Postoperatively  it manifests as increased acqueous flare and cell response,fibrin reaction,posterior synechias and increased capsular opacification.

AIM &OBJECTIVE

To study the intra operative complications and postoperative out come of phacoemulsification  in patients with pseudoexfoliation

MATERIALS AND METHODS

An observational study will be undertaken in all patients with evidence of pseudoexfoliation who underwent phacoemulsification during the period between January 2014 and December 2014  in Giridhar eye institute,kochi .These patients  will be followed up for next one year.All patients will be  provided informed consent.All eyes will be thoroughly  examined preoperatively . BCVA,IOP,anterior chamber depth,gonioscopy A-scan biometry will be done.Detailed slitlamp biomicroscopy under maximal mydriasis will be done to identify any pseudoexfoliation deposition on anterior lens capsule,type and grade of cataract,and the presence of zonular dialysis.Detailed dilated fundus examination will be done in all cases and all these data will be recorded in the protocol sheet.

A standardized phacoemulsification  technique and the same type of  IOL will be used for all cases .CCC will be measured by using a 30cm scale in the TV screen under a microscopic magnification of 10x.Intraoperative observations like difficulty in performing CCC,phakodonesis,zonular dehiscence, posterior capsule tear,vitreous loss, nucleous drop, phaco parameters, pupil stretching techniques ,use of endocapsular ring  all will be recorded .Postoperative examination will include IOP,anterior chamber flare and cell,presence of posterior synechias,capsular change ,visual acuity.A standard postoperative drug regime will be used for all patients and postoperative follow-up in 1month,6month and 1 year will be done by  the same observer.

INCLUSION CRITERION

All patients with evidence of pseudoexfoliation who underwent phacoemulsification during the period between January 2014 and December 2014  in our institution.

EXCLUSION CRITERION

Previous vitreo-retinal  surgey

Previous history of Trauma to eyes

All other causes of Zonular weakness except  pseudoexfoliation

RESULTS OF THE STUDY

The study was successfully completed and the findings were statistically analysed and the final thesis submitted to the National Board of Examinations

 
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