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CTRI Number  CTRI/2018/11/016261 [Registered on: 02/11/2018] Trial Registered Prospectively
Last Modified On: 01/11/2018
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Medical Device
Surgical/Anesthesia 
Study Design  Single Arm Study 
Public Title of Study   Presbyopic implantable lens in adult presbyopic patients with refractive error 
Scientific Title of Study   Safety and Efficacy of the Presbyopic IPCL for correction of Presbyopia with Moderate Myopia and Hyperopia Prospective Clinical Trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Prof Jeewan Singh Titiyal 
Designation  Professor of ophthalmology 
Affiliation  AIIMS 
Address  Room no 491 Dr R P Centre for ophthalmic sciences AIIMS New Delhi
AIIMS Ansari Nagar New Delhi
New Delhi
DELHI
110049
India 
Phone  011-26593146  
Fax    
Email  titiyal@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Prof Jeewan Singh Titiyal 
Designation  Professor of ophthalmology 
Affiliation  AIIMS 
Address  Room no 491 Dr R P Centre for ophthalmic sciences AIIMS New Delhi
AIIMS Ansari Nagar New Delhi
New Delhi
DELHI
110049
India 
Phone  011-26593146  
Fax    
Email  titiyal@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Prof Jeewan Singh Titiyal 
Designation  Professor of ophthalmology 
Affiliation  AIIMS 
Address  Room no 491 Dr R P Centre for ophthalmic sciences AIIMS New Delhi
AIIMS Ansari Nagar New Delhi
New Delhi
DELHI
110049
India 
Phone  011-26593146  
Fax    
Email  titiyal@gmail.com  
 
Source of Monetary or Material Support  
Care Group India, Block No. 310, Village Sim of Dabhasa, Tal. Padra, Dabhasa, Vadodara, Gujarat, 391440, India 
 
Primary Sponsor  
Name  Care Group India 
Address  Care Group India Gujrat 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Prof J S Titiyal  Dr R P Centre for Ophthalmic Sciences  Dr R P Centre for Ophthalmic Sciences, AIIMS, Ansari Nagar New Delhi
New Delhi
DELHI 
9810649942

titiyal@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
AIIMS Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H524||Presbyopia, (2) ICD-10 Condition: H524||Presbyopia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NA  NA 
Intervention  Presbyopic IPCL Implant  Presbyopic IPCL will be implanted for correction of Presbyopia with Moderate Myopia and Hyperopia 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  Bilateral Baseline Refractive Errors between -5.0 to +5.0 D Sph of myopia/Hyperopia (manifest refraction spherical equivalent [MRSE]). A maximum of 4.0 D of manifest refractive cylinder
have documented stable refraction for 12 months before study enrollment (+ 0.5 D, + 1.0 D for high refractive errors)
BSCVA of at least 20/100 in the study eye
Patient should be able to comply with the standardized postoperative follow-up visits through the 3-year study period 
 
ExclusionCriteria 
Details  Anterior Chamber depth < 2.8 mm (measured from the corneal endothelium to the anterior lens capsule)
Endothelial Cell Density (ECD) less than 2000 cells / mm3
History and/or clinical signs of iritis/uveitis, diabetic retinopathy, glaucoma, previous ocular surgery, ocular hypertension, progressive sight-threatening disease other than myopia, pseudoexfoliation, and/or insulin- dependent diabetes
Keratoconus
Monocular vision
Patient is pregnant, plans to become pregnant or is lactating during the course of the study
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Safety Outcomes:
Lens opacity analysis (Lens Opacity Classification System III [LOCS III]) / Pentacam crystalline Lens
Endothelial Cell Density and Morphology (CD, CV)
Measurement of IOP
ASOCT – IPCL vaulting
Effectiveness Outcomes:
Uncorrected visual acuity (UCVA) Distance and near (30cm and 60cm)
Best Spectacle Corrected Visual Acuity (BsCVA) for distance and for near 
Day 1
1 Week (5 to 9 days)
1 Month (3 to 5 weeks)
3 Months (10 to 14 weeks)
6 Months (21 to 26 weeks)
12 Months (11 to 14 months)
24 Months (23 to 27 months)
36 Months (35 to 39 months)  
 
Secondary Outcome  
Outcome  TimePoints 
Anterior Chamber Inflammation (Aqueous cells, flare)
Pigment Dispersion (Iris transillumination defects, Pigment dispersion on endothelium, phakic lens surface, clear lens surface and anterior chamber angle)
Lens thickness
Macular Thickness Changes (Posterior Segment OCT)
Contrast sensitivity
Glare acuity
Operative and post-operative complications
 
Day 1
1 Week (5 to 9 days)
1 Month (3 to 5 weeks)
3 Months (10 to 14 weeks)
6 Months (21 to 26 weeks)
12 Months (11 to 14 months)
24 Months (23 to 27 months)
36 Months (35 to 39 months) 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
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)   01/12/2018 
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="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NONE YET 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Correction of presbyopia remains the major vision problem not adequately addressed by modern refractive surgeryPresbyopia is a multifactorial anatomic problem that leads to a progressive functional loss of the human eye’s ability to focus at near and results in the use of and dependence on near vision spectacles by age 40 to 50 years.Multifocal posterior chamber intraocular lenses (IOLs) have been used in the correction of aphakia for a relatively long period1, providing functional far, intermediate, and near vision and obviating the need for spectacles for near vision in many cases.Presbyopia is frequently associated with other refractive errors, including myopia, hyperopia, and astigmatism. When a presbyopic patient selects refractive surgery, the choices are limited.Refractive lens exchange with a multifocal intraocular lens was a popular method of refractive surgery in presbyopic patients, However near vision in these cases is attained by pseudoaccomodation. Other complications include posterior capsular opacification and retinal detatchment4. A phakic IOL with multifocal refractive technology therefore is an attractive option. In  a pilot study done by Jorge L et al2in the year 2005, in which the potential of an anterior chamber phakic refractive multifocal intraocular lens (IOL) prototype for the correction of near and far vision in those with myopic and hyperopic presbyopia was studied, they found, promising results were obtained with the refractive multifocal phakic IOL prototype. In another study by Caroline Amaral Ferraz et al,done in 2007,similar results with respect to improvement of mean uncorrected visual acuity and refraction data after multifocal phakic intraocular lens Newlife implantation for presbyopia correction was observed. However, established safety criteria (distance and near corrected visual acuity, endothelial cell count and complications) did not confirm the safety of the procedure in the follow-up period. 

There are no published studies on posterior chamber presbyopic phakic IOLs, regarding its efficacy or its safety profile.

 A single study presented at ESCRS Barcelona in 2015, including 5 patients in whom posterior chamber presbyopic phakic IOL were implanted, 4 patients had a UDVA of 1.0 and an uncorrected near visual acuity (UNVA) of  J-1, one patient developed cataract. The mean endothelial cell loss at the end of 1 year is 10%. In a single case with flipped IOL, the endothelial loss was 25%, from 2400 to 1800 at the end of 1year. The specifications of the Presbyopic IPCL manufactured by Contacare are as follows,

The lens device is structurally designed to be implanted in the posterior chamber of the eye. It comprises of a circular optic, two flat haptics placed radially opposite sides of the optic and a vaulted section connecting the optic to the haptic. Each haptic has at least 3 outward protruding pads for fixating the haptic structures in the ciliary sulcus. The vaulted section and the optical section and a transition zone between the two, have at one opening each to allow fluid to pass from between the anterior and posterior chamber. The optical zone consist of concentric annular zones having surfaces separated by slanted steps having surfaces where in the surface of the the concentric zones effect both diffraction and refraction of the incident light while the surface of the steps are devoid substantially devoid of these.

The IPCL is DGCI approved on 16/10/2014 . The implant has also received CE certification on 29 October 2013

 Lacunae in knowledge:No long term study has been done to evaluate the safety and efficacy of  the IPCL to correct Presbyopia with Moderate  Myopia & Hyperopia (with or without astigmatism).

Objective of the study:To report the safety and efficacy outcomes of the IPCL to correct presbyopia with moderate  Myopia & Hyperopia    (with or without astigmatism) at minimum 3 years follow-up duration

 
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