FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2022/12/047983 [Registered on: 08/12/2022] Trial Registered Prospectively
Last Modified On: 07/12/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Other 
Public Title of Study   A study to compare the degree of blurred vision between incisional approaches in cataract surgery at tertiary care centre of Garhwal region 
Scientific Title of Study   Randomized controlled trial of surgical induced astigmatism in cataract patients undergoing phacoemulsification via superior clear corneal incision vs temporal clear corneal incision at tertiary care centre of Garhwal region 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Rangkynsai Marngar 
Designation  Postgraduate Junior Resident Year 1 Ophthalmology Department  
Affiliation  Veer Chandra Singh Garhwali Govt. Institute of Medical Science & Research 
Address  OPD ROOM 61,Department of Ophthalmology,HNB base hospital Srikot District Pauri Garhwal Pin 246174
HNB base hospital Srikot District Pauri Garhwal Pin 246174
Garhwal
UTTARANCHAL
246174
India 
Phone  07005785325  
Fax    
Email  rangkynsaimarngar@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Achyut Narayan Pandey 
Designation  Associate Professor Department of Ophthalmology 
Affiliation  Veer Chandra Singh Garhwali Govt. Institute of Medical Science & Research 
Address  HNB Base hospital Department of Ophthalmology Srikot, District Pauri Garhwal

Garhwal
UTTARANCHAL
246174
India 
Phone  9456792024  
Fax    
Email  achyutpandey@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Achyut Narayan Pandey 
Designation  Associate Professor Department of Ophthalmology 
Affiliation  Veer Chandra Singh Garhwali Govt. Institute of Medical Science & Research 
Address  HNB Base hospital Department of Ophthalmology Srikot, District Pauri Garhwal

Garhwal
UTTARANCHAL
246174
India 
Phone  9456792024  
Fax    
Email  achyutpandey@gmail.com  
 
Source of Monetary or Material Support  
Veer Chandra Singh Garhwali Govt Institute of Medical Science and Research. Address-Srikot Srinagar district Pauri Garhwal Pin 246174 
 
Primary Sponsor  
Name  Veer Chandra Singh Garhwali Govt Institute of Medical Science and Research 
Address  Srikot Srinagar district Pauri Garhwal Pin 246174 
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 AN PANDEY  H. N.B Teaching Hospital.  H.N.B Teaching Hospital. Srinagar,Pauri Garhwal, Garhwal, Uttarakhand - 246174
Garhwal
UTTARANCHAL 		 9870879862

achyutpandey@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE VCSGGIMSR  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H25||Age-related cataract,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Surgical induced astigmatism and Visual acuity  Surgical induced astigmatism is compared in between the two approaches of superior vs temporal incision in phacoemulsificaion. Analysis is done for pre op & post op surgically induced astigmatism in Superior vs Temporal clear corneal 3mm incision. Also analysis for preop and post op unaided visual acuity in Superior vs Temporal clear corneal approach will be done.Patients of both approaches will be followed up for day 1,Day 7, Day 30 and Day 90. 
Intervention  Temporal clear corneal incision and temporal clear corneal incision in phacoemulsification for cataract patients  All phacoemulsification surgeries were done by a single right-handed surgeon (AN) under peribulbar anesthesia. In temporal approach, the surgeon sits at the 9 o’clock position in the case of the right eye and at 3 o’clock position for the left eye. A side port was made at 90° to the planned main port ie, at 12 o’clock in the right eyes and 6 o’clock in the left eyes.In the superior approach, the main port was made at the 12 o’clock position and the side port was made at the 3 o’clock position for both the eyes. The technique for nuclear fragmentation used was direct chop, and the rest of the surgical steps for both the approaches were done as for routine phacoemulsification.Surgical induced astigmatism is compared in between the two approaches. Analysis is done for pre op & post op surgically induced astigmatism in Superior vs Temporal clear corneal 3mm incision. Also analysis for preop and post op unaided visual acuity in Superior vs Temporal clear corneal approach will be done.Patients of both approaches will be followed up for day 1,Day 7, Day 30 and Day 90.  
 
Inclusion Criteria  
Age From  45.00 Year(s)
Age To  85.00 Year(s)
Gender  Both 
Details  1.Age related senile cataract.
2.Patients who were posted for Phacoemulsification cataract surgery.
 
 
ExclusionCriteria 
Details  1.Age below 45 and above 85 years.
2.Corneal surface irregularities.
3.Associated ocular disorders like previous ocular surgeries, history of trauma, glaucoma etc.
4.Combined surgical procedures at the time of surgery like trabeculectomy, pterygium excision.
5.With systemic connective tissue disorders.
6.Inability to give informed consent.
7.Congenital and developmental cataract.
8.Macular degeneration and retinal pathology and those with intra-operative were excluded.
9.Patients with astigmatism of more than three dioptres(D)
10.Those not willing to participate in study and lost to follow-up were excluded subsequently.
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To analyze pre op & post op surgically induced astigmatism in Superior vs Temporal clear corneal 3mm incision by using the following parameters:Preoperative and postoperative Keratometric readings values K1 K2 Axis, Surigally induced astigmatism   assessed at base line Day 0, 7th, 30th and 90th day 
 
Secondary Outcome  
Outcome  TimePoints 
To analyze preop and post op unaided visual acuity in superior vs temporal clear corneal approach by using the following parameters:Preoperative and postoperative undercorrected visual acuity and best corrected visual acuity  90 days 
 
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)   13/12/2022 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [rangkynsaimarngar@gmail.com].

  6. For how long will this data be available start date provided 25-08-2024 and end date provided 25-08-2030?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary   This study is a single blinded randomized control trial of surgical induced astigmatism in cataract patients undergoing phacoemusification via superior clear corneal incision vs temporal clear corneal incision  at tertiary care centre of Garhwal region. Primary outcome to analyze pre-operative & post-operative surgically induced astigmatism in Superior vs Temporal clear corneal 3mm incision by using the parameters of preoperative and postoperative keratometric readings and surgical induced astigmatism at 90 days. Secondary outcome to analyze preoperative and post operative unaided visual acuity in Superior vs Temporal clear corneal approach by using parameters of preoperative and postoperative undercorrected visual acuity and best corrected visual acuity at 90 days. 
Close