| CTRI Number |
CTRI/2025/04/085465 [Registered on: 23/04/2025] 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
|
To Study the Safety and Performance of Cast molded, Preloaded Hydrophobic Intraocular lenses (IOL) in age-related Cataract patients |
|
Scientific Title of Study
|
Evaluation of Safety and visual Performance of Cast molded, Preloaded Hydrophobic Intraocular lenses (IOL) in age-related Cataract patients |
| 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 MadhuShekhar |
| Designation |
Medical Officer |
| Affiliation |
Aravind Eye Hospital Madurai |
| Address |
IOL and Cataract Department
OPD First floor
Room No 105
No1 Anna Nagar
Madurai 625020
Madurai
TAMIL NADU
625020
India |
| Phone |
04524356105 |
| Fax |
|
| Email |
madhushekhardr@aravind.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr MadhuShekhar |
| Designation |
Medical Officer |
| Affiliation |
Aravind Eye Hospital Madurai |
| Address |
IOL and Cataract Department
Aravind Eye Hospital
Madurai
Madurai
TAMIL NADU
625020
India |
| Phone |
04524356105 |
| Fax |
|
| Email |
madhushekhardr@aravind.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr MadhuShekhar |
| Designation |
Chief |
| Affiliation |
Aravind Eye Hospital Madurai |
| Address |
IOL and Cataract Department
Aravind Eye Hospital
Madurai
No 1 Anna Nagar
Madurai
625020
Madurai
TAMIL NADU
625020
India |
| Phone |
04524356105 |
| Fax |
|
| Email |
madhushekhardr@aravind.org |
|
|
Source of Monetary or Material Support
|
| Aurolab
NO 1 Veerapanjan
Sivagangai Main Road
Madurai Tamil Nadu 625020 |
|
|
Primary Sponsor
|
| Name |
Aurolab |
| Address |
No 1 Sivagangai Main Road
Veerapanjan
Madurai 625020 |
| Type of Sponsor |
Other [Ophthalmic and Pharmaceutical manufacturing industry] |
|
|
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 Madhu Shekhar |
Aravind Eye Hospital |
Department of IOL and Cataract Services
First floor OPD
Room No 105
Madurai 625020
Madurai
TAMIL NADU |
0452 4356100
madhushekhardr@aravind.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Aravind Eye Hospital Madurai |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H259||Unspecified age-related cataract, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Cast molded Hydrophobic IOL |
-Cast molded Hydrophobic IOL will be implanted in 102 eyes of 88 patients
-The patients will be followed up for 1 day 1 week 1 month 6 month and 1 year
-The total duration of this study will be 1.5 years |
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1 Senile cataract eligible for phaco emulsification cataract surgery
2 Clear intraocular media other than cataract
3 Age above 40 years
4 BCVA equal to less than 6/12 in the study eye
5 Pre operative corneal astigmatism less than one diopter
6 Able to read understand and provide informed consent |
|
| ExclusionCriteria |
| Details |
1 Uncontrolled Diabetic retinopathy or systemic hypertension or cardiac disorder
2 Pseudo exfoliation
3 Traumatic cataract
4 Small pupil
5 Any pre existing corneal pathologies or dry eyes
6 Post lasik or refractive surgeries
7 Uncontrolled glaucoma or on treatment for glaucoma in either eye
8 Preoperative retinal detachment or clinically significant retinal pathology in the operative eye
9 Congenital cataracts
10 Prior ocular surgery in the study eye |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
-Best Uncorrected Distance Visual Acuity
|
- 1 day
- 1 week
- 1 month
- 6 months
- 1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
-Incidence of PCO formation
-Glistening of IOL |
- 1 day
- 1 week
- 1 month
- 3 month
- 6 months
- 1 year |
|
|
Target Sample Size
|
Total Sample Size="105"
Sample Size from India="105"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
10/05/2025 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
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 main aim of this study is to determine the safety and efficacy of Aurolabs Cast molded Preloaded Hydrophobic Intraocular lenses (IOL) in age related cataract patients -Primary Objective will be Best uncorrected distance visual acuity and Secondary Objective will be Incidence of PCO formation and Glistening of IOL -105 patients meeting the inclusion criteria will be enrolled in this study and written consent will be taken from all the patients -Preoperative examination will include refraction, keratometry slitlamp biomicroscopy noncontact tonometry and detailed fundus examination - Surgical procedure will be the same for all phacoemulsification with Cast molded IOL implantation -Surgeon will record any intra operative complications -Patients will be followed up on 1 day 1week 1 month 6 months and 1 year -Postoperative examination will include Visual acuity Refraction non- contact tonometry Anterior segment and fundus evaluation by slit lamp examination -Glistening and PCO assessment will be performed by slit lamp bio microscopy using high powered magnification and the same will be evaluated by MIYATA SCALE and EPCO respectively -Subjects will be evaluated for occurrence of post-operative complications like Iritis Corneal edema Uveitis Rise in IOP Postop Endophthalmitis Postop CME PCO formation during each follow up -The performance endpoints will be UCDVA BCDVA IOL stability and patients satisfaction The safety endpoints will be occurrence and frequency of adverse events
|