FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/03/083687 [Registered on: 28/03/2025] Trial Registered Prospectively
Last Modified On: 26/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparison between two types of lenses used during eye operation. 
Scientific Title of Study   A comparative study of surgical outcome between iris claw and scleral tuck lens in primary cataract surgery by phacoemulsification in a tertiary care centre 
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 Mohammed Kaderi 
Designation  Postgraduate student  
Affiliation   
Address  Department of ophthalmology, ground floor, AVBRH building, Sawangi Meghe Wardha MAHARASHTRA 442001 India

Wardha
MAHARASHTRA
442001
India 
Phone  8698786925  
Fax    
Email  mkad11@hotmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sachin Daigavane 
Designation  Professor and Head, Department of Ophthalmology 
Affiliation   
Address  Department of ophthalmology, ground floor, AVBRH building, Sawangi Meghe Wardha MAHARASHTRA 442001 India

Wardha
MAHARASHTRA
442001
India 
Phone  9121736568  
Fax    
Email  drsachin391977@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Sachin Daigavane 
Designation  Professor and Head, Department of Ophthalmology 
Affiliation   
Address  Department of ophthalmology, ground floor, AVBRH building, Sawangi Meghe Wardha MAHARASHTRA 442001 India

Wardha
MAHARASHTRA
442001
India 
Phone  9121736568  
Fax    
Email  drsachin391977@gmail.com  
 
Source of Monetary or Material Support  
Datta Meghe Institute of Higher Education and Research, Sawangi, Wardha, India 442001 
 
Primary Sponsor  
Name  Datta Meghe Institute of Higher Education and Research 
Address  Sawangi, Wardha, India 442001 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NA 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Mohammed Kaderi  Acharya Vinoba Bhave Rural Hospital  Room number: 24, Department of Ophthalmology, ground floor, AVBRH building, Sawangi Meghe
Wardha
MAHARASHTRA 		 8698786925

mkad11@hotmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Datta Meghe Institute of Higher Education and Research Institutional Research Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H259||Unspecified age-related cataract,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Iris claw lens  After administering local anesthesia, phacoemulsification will be performed and an iris claw lens will be inserted in the required complicated cases, and post-operative vision, patient satisfaction, and surgical outcome will be assessed at regular intervals of follow-up. 
Intervention  Scleral tuck lens  After administering local anesthesia, phacoemulsification will be performed and a scleral tuck lens will be inserted in the required complicated cases, and post-operative vision, patient satisfaction, and surgical outcome will be assessed at regular intervals of follow-up. 
 
Inclusion Criteria  
Age From  35.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1. Aphakia resulting from current cataract surgery.
2. Patients who provide informed consent
3. Patients who want to attend all follow-up visits.
4. IOL power calculation is performed by a single designated individual
5. Surgery performed by the same surgeon.
 
 
ExclusionCriteria 
Details  1. Pre-existing corneal diseases like keratitis, corneal dystrophy, and corneal opacities.
2. History of recurrent uveitis or severe iris damage.
3. Retinal pathologies like diabetic and hypertensive retinopathy, retinitis pigmentosa, age-related macular degeneration, and maculopathy.
4. Cases of traumatic aphakia.
5. Patients with exaggerated glaucoma.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Iris-claw lenses may offer better stability and fewer complications. On the contrary, scleral tuck lenses provide comparable visual improvement.  Assessment will be done on Day 1, Day 15, Day 30, and Day 90 post-operatively 
 
Secondary Outcome  
Outcome  TimePoints 
Intraoperative and post-operative complications of iris claw lens and scleral tuck lens   Assessment will be done during surgery and Day 1, Day 15, Day 30, and Day 90 post-operatively 
 
Target Sample Size   Total Sample Size="66"
Sample Size from India="66" 
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/ Phase 4 
Date of First Enrollment (India)   15/04/2025 
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="2"
Months="0"
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 researchers here describe the comparison between the iris claw lens and the scleral tuck lens during primary cataract surgery by phacoemulsification. The current study will be conducted for 2 years in the tertiary rural care hospital, Wardha, which is a two-arm open-label randomised control trial that will include 66 patients in total (Group Iris claw lens and Group Scleral tuck lens). Before the patients undergo the intervention trial, the demographic and ophthalmological examination details (visual acuity, intraocular pressure, fundus examination, and biometric measurement) will be collected on the proforma, and after the surgery, the later data (intraoperative and postoperative complications, intraocular pressure, uncorrected and best-corrected visual acuity, lens-induced astigmatism, and patient satisfaction) will be collected on the EXCEL sheet, and the required statistical analysis will be done. Iris claw lenses may offer better stability and fewer complications, while scleral tuck lenses may provide comparable visual improvement. 
Close