| CTRI Number |
CTRI/2024/12/077712 [Registered on: 05/12/2024] Trial Registered Prospectively |
| Last Modified On: |
05/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
A case control study on Scleral fixation of Posterior chamber intraocular lens- Flange Yamane technique vs Glued intrahaptic fixation |
|
Scientific Title of Study
|
Scleral fixation of Posterior chamber Intraocular lens- Flange Yamane technique vs Glued Intrascleral Haptic fixation technique: a case control study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Gnanambiga |
| Designation |
Junior resident |
| Affiliation |
All India institute of medical sciences New Delhi |
| Address |
Room 488 4th floor Department of ophthalmology Dr Rajendra Prasad centre for ophthalmic sciences
Ansari nagar east
All india institute of medical sciences New Delhi 110029
South
DELHI
110029
India |
| Phone |
9047135501 |
| Fax |
|
| Email |
mastibee.99.genius@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajesh Sinha |
| Designation |
Professor |
| Affiliation |
AIIMS New Delhi |
| Address |
Room no 488 4th floor Department of ophthalmology Dr Rajendra Prasad centre for ophthalmic sciences
Ansari nagar east
All india institute of medical sciences New Delhi 110029
South
DELHI
110029
India |
| Phone |
9868937900 |
| Fax |
|
| Email |
sinharaj1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gnanambiga |
| Designation |
Junior resident |
| Affiliation |
AIIMS New Delhi |
| Address |
Room 488 4th floor Department of ophthalmology Dr Rajendra Prasad centre for ophthalmic sciences
Ansari nagar east
AIIMS New Delhi 110029
South
DELHI
110029
India |
| Phone |
9047135501 |
| Fax |
|
| Email |
mastibee.99.genius@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr RP centre for ophthalmic sciences
Ansari nagar east
AIIMS NEW DELHI 110029 |
|
|
Primary Sponsor
|
| Name |
All India Institute of medical sciences New Delhi |
| Address |
All India Institute of medical sciences
(AIIMS)New Delhi |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Gnanambiga |
All india institute of medical sciences |
Room 488
4rd floor
Department of ophthalmology
Dr Rajendra Prasad centre for ophthalmic sciences
All india institute of medical sciences New Delhi 110029
South Delhi
South
DELHI |
9047135501
mastibee.99.genius@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee for Postgraduate Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H270||Aphakia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Flange Yamane technique |
Scleral fixation technique of Intraocular lens fixation in which haptics of lens are fixated by creating flange with low temperature cautery total duration around two hours frequency once |
| Comparator Agent |
Glued intrascleral haptic fixation |
Scleral fixation technique of posterior chamber intraocular lens fixation in which fibrin glue is used to fix ends of lens haptic. Total duration around two hours frequency once |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Aphakia inadequate capsular support
2. Age 18 to 60 years
3. Specular count greater than 1500 cells/mm2
4. Eyes without underlying ocular pathology
|
|
| ExclusionCriteria |
| Details |
1. Age less than 17 yrs and greater than 60 yrs
2. Eyes with underlying ocular pathology, namely keratopathy, glaucoma, retinopathy
3. Eyes with a specular count of less than 1500 /mm2
4. Patients not willing for follow up
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess and compare the clinical outcomes and IOL stability between flange Yamane technique and Glued Intrascleral haptic fixated intraocular lens. |
1 month, 3 month and 6 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to compare intraoperative iop, and postoperative complications between flange Yamane technique and Glued Intrascleral haptic fixated intraocular lens. |
1 month, 3 month and 6 month |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
16/12/2024 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The primary goal of this case control study is to critically evaluate and compare the two revolutionary scleral fixation of intraocular lens approaches - Flanged Yamane technique and Glued intrascleral haptic fixation technique in terms of visual outcomes, intraocular pressure, IOL stability and postoperative complications where 40 aphakic patients coming to RP centre AIIMS Delhi -of age within 18 to 60 years with inadequate capsular support ,no underlying ocular pathology are included and evaluated. 20 patients will be taken as case and 20 as controls and undergo Flanged Yamane technique and Glued intrascleral haptic fixation technique respectively and will be followed up after 1 month, 3 month and 6 month and evaluated and analysed to find out which technique is superior over other in terms of clinical outcomes and complications. |