| 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
|
|
|
Primary Sponsor
|
| Name |
Ministry of Defence |
| Address |
Ministry of Defence, Government of India |
| Type of Sponsor |
Government funding agency |
|
|
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 |
| 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
|
|
|
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
- 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).
- What additional supporting information will be shared?
Response - Study Protocol Response - Informed Consent Form
- Who will be able to view these files?
Response (Others) - nil
- For what types of analyses will this data be available?
Response (Others) - nil
- By what mechanism will data be made available?
Response (Others) - nil
- For how long will this data be available start date provided 27-05-2022 and end date provided 01-06-2027?
Response (Others) - nil
- 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. |