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CTRI Number  CTRI/2022/12/047921 [Registered on: 06/12/2022] Trial Registered Prospectively
Last Modified On: 01/12/2022
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   Changes in the flexibility of the eye after surgery of the retina and what effect that has on eye pressure measurement. 
Scientific Title of Study   Changes in ocular biomechanics following vitreoretinal surgery and its effect on intraocular pressure measurement using different modalities. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shruti M Nair 
Designation  Junior Resident 
Affiliation  Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER) 
Address  Department of Ophthalmology, Jawaharlal Institute of Post-Graduate Medical Education and Research (JIPMER)

Pondicherry
PONDICHERRY
605006
India 
Phone  4132296291  
Fax    
Email  shrutrox@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Geeta Behera 
Designation  Assistant Professor 
Affiliation  Jawaharlal Institute of Post-Graduate Medical Education and Research (JIPMER) 
Address  Department of Ophthalmology, Jawaharlal Institute of Post-Graduate Medical Education and Research (JIPMER)

Pondicherry
PONDICHERRY
605011
India 
Phone  4132296291  
Fax    
Email  geeta.anandaraja@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Geeta Behera 
Designation  Assistant Professor 
Affiliation  Jawaharlal Institute of Post-Graduate Medical Education and Research (JIPMER) 
Address  Department of Ophthalmology, Jawaharlal Institute of Post-Graduate Medical Education and Research (JIPMER)

Pondicherry
PONDICHERRY
605011
India 
Phone  4132296291  
Fax    
Email  geeta.anandaraja@gmail.com  
 
Source of Monetary or Material Support  
JIPMER (intramural fund) 
 
Primary Sponsor  
Name  JIPMER(INTRAMURAL FUNDING) 
Address  Jawaharlal Institute of Post-Graduate Medical Education and Research (JIPMER), Puducherry-605006, India  
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 Shruti M Nair  Jawaharlal Institute of Postgraduate Medical Education and Reseach  Department of Ophthalmology, Jawaharlal Institute of Post-Graduate Medical Education and Research (JIPMER), Puducherry-605006, India
Pondicherry
PONDICHERRY 
4132296291

shrutrox@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
JIPMER Institutional Ethics Committee (JIEC)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H338||Other retinal detachments, (2) ICD-10 Condition: H358||Other specified retinal disorders, (3) ICD-10 Condition: H333||Retinal breaks without detachment, (4) ICD-10 Condition: H330||Retinal detachment with retinal break, (5) ICD-10 Condition: H36||Retinal disorders in diseases classified elsewhere, (6) ICD-10 Condition: H356||Retinal hemorrhage, (7) ICD-10 Condition: H334||Traction detachment of retina, (8) ICD-10 Condition: H431||Vitreous hemorrhage,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Nil  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Patients >18yrs undergoing vitreoretinal surgery in the Department of Ophthalmology, JIPMER. 
 
ExclusionCriteria 
Details  1)Pre-existing glaucoma
2)Pre-existing or emergent corneal pathology (e.g. persistent epithelial defects, opacities, ulcers, severe dry eye disease, keratoconus, corneal dystrophies, degenerations)
3)High myopia
4)Re-surgery 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
i. Corneal hysteresis
ii. IOPg
iii. IOPcc
iv. IOP - iCare value
v. IOP - NCT value
vi. IOP - GAT value
vii. IOP - Tonopen value 
i. Preop
ii. 1 week post op
iii. 1 month post op
iv. 3 months post op 
 
Secondary Outcome  
Outcome  TimePoints 
None  Not applicable 
 
Target Sample Size   Total Sample Size="85"
Sample Size from India="85" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   10/12/2022 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   will be published in a peer reviewed journal 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  
BACKGROUND
Pars plana vitrectomy (PPV) is one of the main surgical methods for management of posterior segment pathologies.Commonly used intraocular tamponadeagents following PPV include either ringer lactate (RL)/ balanced salt solution (BSS) or sterile air, or gases like sulfur hexafluoride (SF6), or perfluoropropane (C3F8) or silicone oil (SO). RL/BSS/sterile air are used for tamponade in simple PPV surgeries like nucleus drop, cortical drop, intraocular lens (IOL) drop, vitreous hemorrhage etc. Intraocular gas as tamponading agent is
used following PPV in macular hole, epiretinal membrane (ERM) or uncomplicated rhegmatogenous retinal detachment (RRD). Silicone oil is used in complex retinal surgeries including RRD associated with proliferative vitreoretinopathy (PVR), giant retinal tears, diabetic macular tractional RD or RD associated with ocular trauma.Scleral buckles are used for external support in simple phakic retinal detachments while encircling scleral bands are used in conjunction with PPV and SO tamponade in complex RD associated
with PVR and/or choroidal detachment. PPV surgeries and scleral buckles or encircling scleral bands can cause significant changes in the axial length of the eyeball, induce refractive errors and also cause alteration in the corneal biomechanics. Viscoelastic materials exhibit characteristics of both, elasticity as well as viscosity, resulting in energy
dissipation when stress is applied. This is known as hysteresis. The cornea has viscoelastic property, giving it the quality of hysteresis. Currently two devices are commercially available for measurement of the corneal biomechanical properties–the Ocular Response Analyser (ORA) and the Corvis ST. The ORA is based on noncontact tonometer technology, which uses a jet of air to applanate the cornea and an electro-optical system to measure the applanation pressure. 
RELEVANCE
In recent years, there has been growing interest in the ocular biomechanical properties that influence intraocular pressure measurements and are independent risk factors
for glaucoma. Vitreoretinal surgery by virtue of its effect on the entire globe, affects ocular biomechanics. However, there is very sparse literature on this. Also, the effect of intraocular tamponade and external buckling on ocular biomechanics merits further evaluation.
NOVELTY
A study detecting the changes in ocular biomechanics following vitreoretinal surgery and the effect of tamponade (silicone oil injection, gas injection) and scleral buckle has not been done before and herein lies the novelty of our study.

OBJECTIVES
A. Among patients undergoing vitreoretinal surgery,
1. To compare corneal hysteresis pre-operatively and post-operatively at 1 week, 1 month and 3 months.
2. To evaluate the effect of tamponade (ringer lactate, sterile air, silicone oil, gas) and scleral buckle or band on corneal hysteresis.

B. Among patients undergoing vitreoretinal surgery,
1. To compare intraocular pressure measurement by NCT, GAT, iCare and Tonopen
2. To assess the influence of change in corneal hysteresis on IOP measurement by NCT, GAT, iCare and Tonopen following vitreoretinal surgery.
 
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