| 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 |
|
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Source of Monetary or Material Support
|
|
|
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 |
|
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Details of Secondary Sponsor
|
|
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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 |
|
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Regulatory Clearance Status from DCGI
|
|
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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, |
|
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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 |
|
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Method of Generating Random Sequence
|
Not Applicable |
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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 |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| None |
Not applicable |
|
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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. |