| CTRI Number |
CTRI/2023/01/049015 [Registered on: 16/01/2023] Trial Registered Prospectively |
| Last Modified On: |
01/02/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [LASER THERAPY] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to see the effect of procedure used to break opacification on Intraocular lens after cataract surgery on vision, pressure of the eye, depth of anterior chamber and macular thickness on the basis of energy used during the procedure.
|
|
Scientific Title of Study
|
Randomised controlled trial of effect of ND-YAG laser on refraction, intraocular pressure IOP, anterior chamber depth and macular thickness in patients with posterior capsule opacification on the basis of energy level. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jigyasa singh |
| Designation |
post graduate student |
| Affiliation |
veer chandra singh garhwali government institute of medical science and research |
| Address |
Department of ophthalmology
HNB base hospital
srikot
srinagar
Garhwal
UTTARANCHAL
246174
India |
| Phone |
8755729355 |
| Fax |
|
| Email |
jigyasasingh2013@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Achyut narayan pandey |
| Designation |
Associate professor |
| Affiliation |
veer chandra singh garhwali government institute of medical science and research |
| Address |
Department of ophthalmology
HNB base hospital
srikot
srinagar
Garhwal
UTTARANCHAL
246174
India |
| Phone |
9456792024 |
| Fax |
|
| Email |
achyutpandey@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Jigyasa singh |
| Designation |
post graduate student |
| Affiliation |
veer chandra singh garhwali government institute of medical science and research |
| Address |
Department of ophthalmology
HNB base hospital
srikot
srinagar
UTTARANCHAL
246174
India |
| Phone |
8755729355 |
| Fax |
|
| Email |
jigyasasingh2013@gmail.com |
|
|
Source of Monetary or Material Support
|
| veer chandra singh garhwali government institute of medical science and research |
|
|
Primary Sponsor
|
| Name |
VEER CHANDRA SINGH GARHWALI GOVERNMENT INSTITUTE OF MEDICAL SCIENCE AND RESEARCH |
| Address |
Department of ophthalmology
HNB base hospital
srikot
srinagar |
| Type of Sponsor |
Government medical college |
|
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Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Jigyasa singh |
Hnb base hospital |
Department of ophthalmology
opd room number 61
Garhwal
UTTARANCHAL |
8755729355
jigyasasingh2013@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee VCSGIMSR |
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: H59-H59||Intraoperative and postprocedural complications and disorders of eye and adnexa, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
ND YAG LASER POSTERIOR CAPSULOTOMY |
ND YAG LASER A NON INVASIVE TECHNIQUE TO TREAT POSTERIOR CAPSULE OPACIFICATION TO BE PERFORMED IN PSEUDOPHAKIC PATIENTS WITH BEST CORRECTED VISUAL ACUITY 6/9 AFTER 3-6 MONTHS OF CATARACT SURGERY |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
CASES WITH UNCOMPLICATED MANUAL SMALL INCISION CATARACT SURGERY OR PHACOEMULSIFICATION WITH POSTERIOR CHAMBER INTRAOCULAR LENS IN THE BAG.
NO ASSOCIATED OCULAR DISORDERS LIKE PREVIOUS OCULAR SURGERIES, HISTORY OF TRAUMA, GLAUCOMA.
NO ASSOCIATED SYSTEMIC DISORDERS
|
|
| ExclusionCriteria |
| Details |
COMPLICATIONS DURING CATARACT SURGERY OR DURING THE POSTOPERATIVE PERIOD.
DIAGNOSED CASES OF GLAUCOMA.
PATIENTS WITH CORNEAL OPACITIES, RETINAL DISEASES, UVEITIS, OPTIC NEUROPATHY.
OPHTHALMIC SURGERIES PRIOR TO ND YAG LASER POSTERIOR CAPSULOTOMY TREATMENT.
CORNEAL SURFACE IRREGULARITIES.
INABILITY TO GIVE INFORMED CONSENT |
|
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Method of Generating Random Sequence
|
Other |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
| Changes in Intraocular pressure, refraction, anterior chamber depth and macular thickness |
variables to be measured before the procedure and 1 hour after the procedure |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| change in intraocular pressure, refraction, anterior chamber depth and macular thickness |
measured 1 week after the procedure |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
20/01/2023 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NONE YET |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
To see the effect of ND YAG laser capsulotomy a non invasive procedure used to treat patients with posterior capsule opacification on intraocular pressure, refraction, anterior chamber depth and macular thickness before the procedure 1 hour and 1 month after the procedure. |