| CTRI Number |
CTRI/2026/04/109105 [Registered on: 22/04/2026] Trial Registered Prospectively |
| Last Modified On: |
22/04/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
feasibility study evaluating the safety and effectiveness
of a novel handheld capsulotomy device during cataract surgery |
|
Scientific Title of Study
|
A study evaluating the safety and effectiveness of a novel capsulotomy device during cataract surgery |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr P Sathyan |
| Designation |
Principal Investigator |
| Affiliation |
Sathyan Eye Care Hospital & Coimbatore Glaucoma Foundation |
| Address |
#78, Om Sakthi Nagar, Off. Trichy Road
Sowripalayam Pirivu, Ramanathapuram
Coimbatore
TAMIL NADU
641045
India |
| Phone |
919443259148 |
| Fax |
914222325565 |
| Email |
dr.sathyan@sathyaneye.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr P Sathyan |
| Designation |
Principal Investigator |
| Affiliation |
Sathyan Eye Care Hospital & Coimbatore Glaucoma Foundation |
| Address |
#78, Om Sakthi Nagar, Off. Trichy Road
Sowripalayam Pirivu, Ramanathapuram
Coimbatore
TAMIL NADU
641045
India |
| Phone |
919443259148 |
| Fax |
914222325565 |
| Email |
dr.sathyan@sathyaneye.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr P Sathyan |
| Designation |
Principal Investigator |
| Affiliation |
Sathyan Eye Care Hospital & Coimbatore Glaucoma Foundation |
| Address |
#78, Om Sakthi Nagar, Off. Trichy Road
Sowripalayam Pirivu, Ramanathapuram
Coimbatore
TAMIL NADU
641045
India |
| Phone |
919443259148 |
| Fax |
914222325565 |
| Email |
dr.sathyan@sathyaneye.com |
|
|
Source of Monetary or Material Support
|
| Sathyan Eye Care Hospital & Coimbatore Glaucoma Foundation, #77, Om Sakthi Nagar, Trichy Road, Sowripalayam Pirivu,
Ramanathapuram, Coimbatore - 641045,
Tamil Nadu, India. |
|
|
Primary Sponsor
|
| Name |
Sathyan Eye Care Hospital & Coimbatore Glaucoma Foundation |
| Address |
#78, Om Sakthi Nagar, Off. Trichy Road, Sowripalayam Pirivu, Ramanathapuram,
Coimbatore - 641045, India. |
| 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 P Sathyan |
Sathyan Eye Care Hospital & Coimbatore Glaucoma Foundation |
#78, Om Sakthi Nagar, Off. Trichy Road,
Sowripalayam Pirivu, Ramanathapuram,
Coimbatore - 641045, India.
Coimbatore
TAMIL NADU |
919443259148
914222325565
dr.sathyan@sathyaneye.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sathyan Eye Care Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H269||Unspecified cataract, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not Applicable |
Not Applicable |
| Intervention |
The Atlas F-0200 Device |
The Atlas F-0200 is an advanced handheld capsulotomy device specifically engineered for precision anterior capsulotomy during cataract surgery. At the heart of the system is a reusable,
ergonomically designed applicator that provides surgeons with comfort and control during delicate
intraocular procedures. The applicator is powered by a compact, rechargeable control unit, optimized for both mobility and extended use in operating rooms or outreach settings with limited
infrastructure. This configuration supports repeated procedures without the need for bulky or
stationary power supplies, making it ideal for both high-volume surgical centers and portable mission-based care. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1.Subjects must be 18 years of age or older on the date the ICF was signed.
2.Subjects must have the capability to understand and provide written informed consent on the Institutional Review Board (IRB) approved ICF.
3.Subjects must have a clinically significant operable cataract(cortical, nuclear, subcapsular, or combination) as determined by the medical judgement of the Investigator, in at least one eye that is considered amenable to treatment with phacoemulsification or lens softening cataract extraction and capsular IOL implantation.
4. Subjects must have clear cornea and normal anterior and posterior segment.
5. Subjects must be willing and able to comply with all treatment and follow-up study visits and procedures. |
|
| ExclusionCriteria |
| Details |
1. Subjects who have used an investigational drug or device within 30 days prior to entry into this study and/or will participate in another investigation during the period of study participation.
2. Subjects who have any corneal pathology (e.g., significant scarring, guttata, inflammation, edema, dystrophy, etc.) in the study eye.
3. Subjects who have significant anterior segment pathology that might increase intraoperative risk (e.g., pseudoexfoliation, synechiae, iris atrophy, traumatic cataract, lens subluxation, traumatic zonulolysis, zonular dialysis, evident zonular weakness or dehiscence, hypermature or brunescent cataract, etc.) in the study eye.
4. Subjects who have uncontrolled glaucoma in the study eye.
5. Subjects who have active proliferative diabetic retinopathy or severe non-proliferative diabetic retinopathy in the study eye.6. Subjects who have a congenital ocular anomaly (e.g., aniridia, congenital cataract) in the study eye.
7. Subjects who have a history of chronic or recurrent inflammatory eye disease (e.g., iritis, scleritis, iridocyclitis, or rubeosis iridis) in
the study eye.
8. Subjects who have had previous corneal surgery in the study eye.
9. Subjects with any active preoperative infectious conjunctivitis,keratitis, or uveitis in either eye within 30 days prior to surgery.
10. Surgeon to assess dilation and decide if the patient has adequate dilation (approx. 6.0mm --subjective assessment by surgeon)
11. Subjects with abnormal pupillary dilation dynamics (as determined by the medical judgement of the investigator) or eccentric or ectopic pupils in either eye.
12. Subjects who may be expected to require a combined or other secondary surgical procedure in the study eye.
13. Females of childbearing potential (those who are not surgically sterilized or at least 12 months postmenopausal) are excluded from enrollment in the study if they are nursing, lactating, currently pregnant or plan to become pregnant during the study. Females of childbearing potential must be willing to practice effective contraception for the duration of the study.
14. Subjects with any other serious ocular pathology or underlying systemic medical condition (e.g., uncontrolled diabetes) or circumstances that, based on the Investigator’s judgement, poses a concern for the subjects’ safety or could confound the results of the study. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| a)incidence of adverse events; b)Slit lamp findings. |
1)Screening (-60 to -1 day)
2)Operative: (0 day)
3)Day 1: (1 day)
4)Week 1: (5-9 days)
5)Week 4: (21-35 days)
6)6 months
7)1 year
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
a)Complete capsulotomy
b)Completed removal of the cataractous lens. |
1)Screening (-60 to -1 day)
2)Operative: (0 day)
3)Day 1: (1 day)
4)Week 1: (5-9 days)
5)Week 4: (21-35 days)
6)6 months
7)1 year
|
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
06/05/2026 |
| 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="8"
Days="15" |
|
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
|
Cataracts, characterized by the clouding of the eye’s natural lens, are a leading cause of vision impairment worldwide. Cataract surgery, one of the most commonly performed surgical procedures, involves the removal of the opacified lens and its replacement with an artificial intraocular lens (IOL). The procedure has evolved significantly over decades, becoming safer and more efficient. The Atlas F-0200 is a handheld, powered capsulotomy device designed to create a precise and controlled anterior capsulotomy. The device operates by delivering localized capsulotomy energy from a power designed in a pulse-width modulated and controlled closed-loop fashion through a microelectrode tip to ablate the anterior capsule. The capsulotomy energy creates a controlled thermal field that precisely cleaves the anterior capsule in a desired dimension and shape with no damage to adjacent ocular tissues.
Subjects Visit Schedule: Screening (-60 to -1 day), Operative: (0 day), Day 1: (1 day), Week 1: (5-9 days), Week 4: (21-35 days), 6 months, 1 year |