| CTRI Number |
CTRI/2023/06/053566 [Registered on: 05/06/2023] Trial Registered Prospectively |
| Last Modified On: |
22/04/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Clinical trial to study the effect and Safety of Novel suture device S-FIX in patients undergoing Scleral fixated IOL surgery |
|
Scientific Title of Study
|
To assess the safety and efficacy of Novel Cannulated
Suture Thread Device for Easy Scleral Fixation of a Multipiece Intraocular Lens (S-FIX) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR Prabhu Baskaran |
| Designation |
Medical Consultant, Vitreo-retina Department |
| Affiliation |
Aravind Eye Hospital |
| Address |
Department of Vitreo retina
Aravind Eye Hospital
Room No 205
Second floor Retina OPD Block
No 10 Poonamallee High Road Noombal
Chennai
TAMIL NADU
600077
India |
| Phone |
914440956100 |
| Fax |
|
| Email |
prabubaskaran@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR Prabhu Baskaran |
| Designation |
Medical Consultant, Vitreo-retina Department |
| Affiliation |
Aravind Eye Hospital |
| Address |
Department of Vitreo retina
Aravind Eye Hospital
Room No 205
Second floor Retina OPD Block
No 10 Poonamallee High Road Noombal
Chennai
TAMIL NADU
600077
India |
| Phone |
914440956100 |
| Fax |
|
| Email |
prabubaskaran@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR Prabhu Baskaran |
| Designation |
Medical Consultant, Vitreo-retina Department |
| Affiliation |
Aravind Eye Hospital |
| Address |
Department of Vitreo retina
Aravind Eye Hospital
Room No 205
Second floor Retina OPD Block
No 10 Poonamallee High Road Noombal
Chennai
TAMIL NADU
600077
India |
| Phone |
914440956100 |
| Fax |
|
| Email |
prabubaskaran@gmail.com |
|
|
Source of Monetary or Material Support
|
| Aurolab
No 1 Sivagangai Main Road
Veerapanchan
Madurai
625020 |
|
|
Primary Sponsor
|
| Name |
Aurolab |
| Address |
No 1 Sivagangai Main Road
Veerapanchan
Madurai 625020 |
| Type of Sponsor |
Other [Ophthalmic device and drug manufacturing unit ] |
|
|
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 Prabhu Baskaran |
Aravind Eye Hospital, Chennai |
Vitreo retina department
OPD Block
2 nd floor
Chennai
TAMIL NADU |
9940152529
prabubaskaran@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Aravind Eye Hospital Chennai |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H598||Other intraoperative and postprocedural complications and disorders of eye and adnexa, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
S FIX device |
The S FIX device used for Intra ocular Haptic fixation in the sclera during Scleral fixated intraocular surgeries
It is made of medical grade Stainless steel surgical needle 5 0 nylon suture and polyimide tube.
The suture needle is crimped with a suture thread which is attached to polyimide tube on the other end.
This device is used to exteriorize the haptics of a multipiece intraocular lens during the scleral fixated intra ocular lens surgery. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
a) All patients with aphakia who require SFIOL implantation
b) Both post cataract surgery and post trauma aphakia are included |
|
| ExclusionCriteria |
| Details |
a) History of glaucoma or uveitis
b) Any other retinal pathology other than dislocated nucleus or intraocular lens
c) Penetrating keratoplasty and any other combined procedures
d) Monocular patients
e) Pediatric age group less than 18 years of age
f) Patients who are not willing to consent for the procedure |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| percentage of patients showing 1-2 lines of improvement in BCVA chi square test |
45 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
-Intraoperative and post-operative complications-Percentage (Categorical)
-IOL tilt assessment-percentage of eyes with tilt and mean IOL tilt in degree, continuous variable
-Difference between pre-operative and POD 45 corneal endothelial cell count (wilcoxan signed rank test)
Difference between mean pre-operative CMT and CMT at POD 45 (wilcoxan signed rank test) |
45 days |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="31" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
13/06/2023 |
| Date of Study Completion (India) |
21/12/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Scleral fixation of a multipiece intraocular lens (SFIOL) is an established modality for surgical correction of aphakia. The two most crucial steps of SFIOL surgery are exteriorization of the haptic and fixation of the same intrasclerally. Various techniques have been described in the literature to constantly simplify these steps. Most techniques differ in the way the haptics are fixed. Appropriate and adequate fixation of the haptic of a multipiece intraocular lens inside the scleral groove is a key component in SFIOL surgeries. Conventional methods of fixing the haptic require either specialized forceps, additional surgical steps like scleral flap creation or additional consumables like bio fibrin glue. Here, we describe a novel cannulated suture thread device (S-FIX) for easy scleral fixation of a multipiece intraocular lens. The S-FIX technique does not require conjunctival peritomy, specialized vitreo-retinal forceps, flap, flange or glue. Aphakic patients who require SFIOL implantation will be recruited. after obtaining consent the SFIOL surgery will be done using S-Fix device. All intra-operative complications will be noted. Post-operative follow-up will be on day 1, day 14, and day 45. Post operative follow-up include Refraction, specular microscopy and OCT. ASOCT will be done on POD 45 and IOL tilt will be measured using image J software. All post operative complications will be noted. |