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CTRI Number  CTRI/2022/06/043113 [Registered on: 09/06/2022] Trial Registered Prospectively
Last Modified On: 21/09/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison in ease of Cataract surgery in patients with poorly dilating pupils using 2 different device 
Scientific Title of Study   A Comparative Study of B-HEX pupil expander versus Malyugin ring in Management of Cataracts with Small Pupils 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Simple Gupta 
Designation  Classified Specialist (Ophthalmology) / Associate Professor 
Affiliation  Command Hospital (SC) 
Address  Dept of Ophthalmology Command Hospital (SC) Wanowrie Pune Camp
10/6, Stavley road colony Near Wanowrie Post Office Adjoining Command Hospital (SC) Pune Camp-411040
Pune
MAHARASHTRA
411040
India 
Phone  8717834257  
Fax    
Email  drsimplegupta7402@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Simple Gupta 
Designation  Classified Specialist (Ophthalmology) / Associate Professor 
Affiliation  Command Hospital (SC) 
Address  Dept of Ophthalmology Command Hospital (SC) Wanowrie Pune Camp
10/6, Stavley road colony Near Wanowrie Post Office Adjoining Command Hospital (SC) Pune Camp-411040
Pune
MAHARASHTRA
411040
India 
Phone  8717834257  
Fax    
Email  drsimplegupta7402@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Simple Gupta 
Designation  Classified Specialist (Ophthalmology) / Associate Professor 
Affiliation  Command Hospital (SC) 
Address  Dept of Ophthalmology Command Hospital (SC) Wanowrie Pune Camp
10/6, Stavley road colony Near Wanowrie Post Office Adjoining Command Hospital (SC) Pune Camp-411040
Pune
MAHARASHTRA
411040
India 
Phone  8717834257  
Fax    
Email  drsimplegupta7402@gmail.com  
 
Source of Monetary or Material Support  
Ministry of Defence 
 
Primary Sponsor  
Name  Ministry of Defence 
Address  Ministry of Defence, Government of India 
Type of Sponsor  Government funding agency 
 
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 Simple Gupta  Command Hospital (SC), Pune  Dept of Ophthalmology
Pune
MAHARASHTRA 
8717834257

drsimplegupta7402@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee AFMC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H251||Age-related nuclear cataract, (2) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  B-HEX pupil expander in the Management of Cataracts with Small Pupils  32 patients of Cataract with non-dilating pupils presenting to the Ophthalmology OPD of this tertiary care hospital, selected by randomisation using computerised random table, would be included in the intervention after securing necessary informed consent.The surgery would be performed by experienced surgeons via clear corneal incision. Intra operatively B HEX pupil expander would be inserted to expand the pupil mechanically and rest of surgery would proceed as per convention. Foldable Intra ocular lens will be implanted. The operating time, ease of insertion, occurrence of intra operative complications like PCR, Zonular dialysis will be documented. Post-operative outcome measures like visual acuity, cosmetic appearance of pupil/pupil distortion, corneal oedema, macular oedema and inflammation will also be documented and compared with the other arm.  
Comparator Agent  Malyugin ring in Management of Cataracts with Small Pupils  32 patients of Cataract with non-dilating pupils presenting to the Ophthalmology OPD of this tertiary care hospital, selected by randomisation using computerised random table, would be included in the intervention group after securing necessary informed consent.The surgery would be performed by experienced surgeons via clear corneal incision. Intra operatively Malyugin Ring would be inserted to expand the pupil mechanically and rest of surgery would proceed as per convention. Foldable Intra ocular lens will be implanted. The operating time, ease of insertion, occurrence of intra operative complications like PCR, Zonular dialysis will be documented. Post-operative outcome measures like visual acuity, cosmetic appearance of pupil/pupil distortion, corneal oedema, macular oedema and inflammation will also be documented and compared with the other arm.  
 
Inclusion Criteria  
Age From  45.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Patients being worked up for Phaco emulsification with PCIOL implantation with pupils not dilating more than 4 mm. 
 
ExclusionCriteria 
Details  Patient requiring combined Corneal, glaucoma or retinal procedure and patients with pre-existing macular oedema, post uveitis irregular pupils. 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the post-operative iris distortion rate after Cataract surgeries with small pupils performed with B-HEX pupil expander versus Malyugin ring  Post operative period 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the post-operative iris distortion rate after Cataract surgeries with small pupils performed with B-HEX pupil expander versus Malyugin ring  Immediately and 1 month post operatively 
 
Target Sample Size   Total Sample Size="64"
Sample Size from India="64" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="64" 
Phase of Trial   N/A 
Date of First Enrollment (India)   10/06/2022 
Date of Study Completion (India) 30/06/2023 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
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 -  Study Protocol
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response (Others) -  nil

  4. For what types of analyses will this data be available?
    Response (Others) -  nil

  5. By what mechanism will data be made available?
    Response (Others) -  nil

  6. For how long will this data be available start date provided 27-05-2022 and end date provided 01-06-2027?
    Response (Others) -  nil

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary
Modification(s)  

                       A total of 64 patients of Cataract with non-dilating pupils presenting to the Ophthalmology OPD of this tertiary care hospital would be included in the study after securing necessary informed consent. Detailed ophthalmic evaluation of the selected subjects would be performed including best corrected visual acuity, anterior segment evaluation by slit lamp biomicroscopy, grade of cataract and posterior segment evaluation and USG B scan in case of hazy fundus view. These patients would then be sent for obtaining pre anaesthetic clearance The patients will then be randomised into two treatment arms using computerised random table. The surgery would be performed by experienced surgeons via clear corneal incision. Intra operatively B HEX pupil expander or Malyugin ring would be inserted to expand the pupil mechanically and rest of surgery would proceed as per convention. Foldable Intra ocular lens will be implanted. The operating time, ease of insertion, occurrence of intra operative complications like PCR, Zonular dialysis will be documented. Post-operative outcome measures like visual acuity, cosmetic appearance of pupil/pupil distortion, corneal oedema, macular oedema and inflammation will also be documented and compared between the two arms. Mean age at presentation was 70.5±10.12 years. Most common cause for small pupil was tamsulosin therapy. MR causes significantly more pupillary distortion in the postoperative period compared to B-Hex ring. Though, both the rings cause pupillary distortion, these devices expand the surgical area adequately, ease the procedure, decrease risk of complications and results in good functional visual outcomes.

 
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