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CTRI Number  CTRI/2024/06/069054 [Registered on: 18/06/2024] Trial Registered Prospectively
Last Modified On: 16/06/2024
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   Comparative evaluation of decrease in corneal cell count in mature cataract following laser assisted cataract surgery in four quadrants as compared to full softening. 
Scientific Title of Study   COMPARATIVE EVALUATION OF CORNEAL ENDOTHELIAL CELL LOSS IN GRADE 3 CATARACT FOLLOWING FEMTOSECOND LASER ASSISTED CATARCT SURGERY, FOUR QUADRANT VERSUS FULL SOFTENING:RANDOMISED CONTROLLED TRIAL 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Kanchan Mala 
Designation  Post Diploma DNB 
Affiliation  Northern Railway Central Hospital 
Address  Room 4 Department of Ophthalmology ground floor Northern Railway Central Hospital Aram Bagh Paharganj New Delhi

Central
DELHI
110055
India 
Phone  8789035592  
Fax    
Email  kanchanrims2009@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr. SK Choudhary 
Designation  Assistant Chief Health Director 
Affiliation  Northern Railway Central Hospital 
Address  Room 4 Department of Ophthalmology ground floor Northern Railway Central Hospital Aram Bagh Paharganj New Delhi

Central
DELHI
110055
India 
Phone  9717630563  
Fax    
Email  SHAILENDERCHOUDHARY@REDIFFMAIL.COM  
 
Details of Contact Person
Public Query
 
Name  Dr. SK Choudhary 
Designation  Assistant Chief Health Director 
Affiliation  Northern Railway Central Hospital 
Address  Room 4 Department of Ophthalmology ground floor Northern Railway Central Hospital Aram Bagh Paharganj New Delhi

Central
DELHI
110055
India 
Phone  9717630563  
Fax    
Email  SHAILENDERCHOUDHARY@REDIFFMAIL.COM  
 
Source of Monetary or Material Support  
Northern Railway Central Hospital Aram Bagh Paharganj New Delhi 110053 India 
 
Primary Sponsor  
Name  Northern Railway Central Hopital 
Address  Room 4 Department of Ophthalmology ground floor Northern Railway Central Hospital Aram Bagh Paharganj New Delhi 
Type of Sponsor  Research institution and hospital 
 
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 
Kanchan Mala  Northern Railway Central Hospital  Room 4 Department of Ophthalmology ground floor Northern Railway Central Hospital Aram Bagh Paharganj New Delhi
Central
DELHI 
8789035592

kanchanrims2009@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE NORTHERN RAILWAY CENTRAL HOSPITAL  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Evaluation of corneal endothelial cell loss in grade 3 cataract following femtosecond laser assisted cataract surgery in four quadrants  After confirming patient fit for surgery patient is advised for Ketomar eye drop Gatifloxacin and Ketorolac ophthalmic solution pre operatively one day prior to surgery. On the day of surgery patient is dilated with i trop plus. One patient is given envelope 1 and second patient is given envelop 2. The consultant then performs the surgery. Patient for FLACS will be made to lie down flat on table under AMO FLACS machine. Eye to be operated will be docked anterior segment imaging performed and vacuum will be created. Rhexis size nuclear fragmentation 4 pieces and corneal incision site and size selected. Femtosecond laser will be fired and vacuum released .The patient is shifted to another table having STELLARIS -PC Phaco machine B n L and microscope. Here the patient is 1st given topical anesthesia having lignocaine .One drop of povidone iodine solution is instilled into the conjunctival sac to eliminate local saprophytic microbiological flora. A sterile self-adhesive plastic drape is applied to the skin on and around the eyelids and the eyelashes are excluded from the operative field by folding the edges of the drape around them and inserting a self-retaining speculum to hold the lids open. Primary incision is created or opened by 2.8mm keratome if not made with laser and hydration is done by hydration cannula after removing the anterior capsule . Viscoelastic substance is instilled and phaco probe is inserted to aspirate the cortex. Residual cortical matter is aspirated manually using a two way irrigation aspiration cannula or an auto mated irrigation aspiration probe. A posterior chamber intraocular lens implanted in the bag. Residual viscoelastic substances are aspirated at the end of surgery. After ensuring wound integrity eye is patched after instilling vigamox. Post operatively on Day 1 Day 7 patient vision will be recorded using Snellen chart. On day 1 day 7 and day 30 endothelial cell count and central corneal thickness will be measured using specular microscope. Slit lamp examination to assess conjunctiva cornea anterior chamber pupil implanted IOL and fundus examination using 90D will be done on every visit.  
Comparator Agent  Evaluation of corneal endothelial cell loss in grade 3 cataract following femtosecond laser assisted cataract surgery in full softening.  After confirming patient fit for surgery patient is advised for Ketomar eye drop Gatifloxacin and Ketorolac ophthalmic solution pre operatively one day prior to surgery. On the day of surgery patient is dilated with i trop plus. One patient is given envelope 1 and second patient is given envelop 2. The consultant then performs the surgery. Patient for FLACS will be made to lie down flat on table under AMO FLACS machine. Eye to be operated will be docked anterior segment imaging performed and vacuum will be created. Rhexis size nuclear fragmentation full softening and corneal incision site and size selected. Femtosecond laser will be fired and vacuum released .The patient is shifted to another table having STELLARIS PC Phaco machine B n L and microscope. Here the patient is 1st given topical anesthesia having lignocaine .One drop of povidone iodine solution is instilled into the conjunctival sac to eliminate local saprophytic microbiological flora. A sterile self-adhesive plastic drape is applied to the skin on and around the eyelids and the eyelashes are excluded from the operative field by folding the edges of the drape around them and inserting a self-retaining speculum to hold the lids open. Primary incision is created or opened by 2.8mm keratome if not made with laser and hydration is done by hydration cannula after removing the anterior capsule . Viscoelastic substance is instilled and phaco probe is inserted to aspirate the cortex. Residual cortical matter is aspirated manually using a two way irrigation aspiration cannula or an auto mated irrigation aspiration probe. A posterior chamber intraocular lens implanted in the bag. Residual viscoelastic substances are aspirated at the end of surgery. After ensuring wound integrity eye is patched after instilling vigamox.  
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  85.00 Year(s)
Gender  Both 
Details  1.IMSC Grade III nuclear sclerosis (LOCS)
2.Any gender
3.Pupil dilation (size more than6mm)
4.Visual acuity less than 6/12
5.No previous ocular surgery or disease affecting corneal endothelium.
 
 
ExclusionCriteria 
Details  1. Pathology of corneal endothelium.
2. Patients with neck and back rigidity.
3. Advanced glaucoma
4. ACD less than 3MM
5. Complicated cataract. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare mean corneal endothelial cell loss by analysing decrease in endothelial count in absolute number per mm square using specular microscope both ,four quadrant versus full softening nuclear fragmentation.  pre-op and post op day 1 day7 day 30 . 
 
Secondary Outcome  
Outcome  TimePoints 
● To compare central corneal thickness by analysing change in corneal thickness in microns using specular microscope pre and post operatively in both the groups.  pre-op and post op day 1 day7 day 30 . 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   27/06/2024 
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="0"
Months="11"
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  

After informed, written and explained consent will be taken from the patient for their inclusion in study. Pre-op full ophthalmologic examination will be done on each patient, including visual acuity with Snellen’s chart, intraocular pressure recorded via non contact tonometer (Shin Nippon) , endothelial cell count and central corneal thickness using specular microscope (Tomey) keratometry, axial length, IOL power calculation and the formula using optical biometry. Patient is dilated with itrop plus drops to examine complete anterior segment& posterior segment examinations with slit lamp biomicroscopy, fundus status with 90 D lens and to rule out any ocular pathology. Lens opalescence is graded after which via The Lens Opacities Classification System (LOCS) III grading score. Other investigations like blood sugar fasting and post prandial and ECG are done.

After confirming patient fit for surgery, patient is advised for ketomar eye drop (gatifloxacin and ketorolac ophthalmic solution) pre operatively one day prior to surgery. On the day of surgery, patient is dilated with itrop plus. The patient is then asked to choose 1 envelope. The consultant then performs the surgery.

Patient for FLACS will be made to lie down flat on table under AMO FLACS machine. Eye to be operated will be docked; anterior segment imaging performed and vacuum will be created. Rhexis size, nuclear fragmentation (4 pieces) and corneal incision (site and size) selected. Femto laser will be fired and vacuum released. The patient is shifted to another table having STELLARIS -PC Phaco machine (B n L) and microscope. Here the patient is 1st given topical anesthesia having 4% lignocaine .One drop of 5% povidone-iodine solution is instilled into the conjunctival sac to eliminate local saprophytic microbiological flora. A sterile, self-adhesive plastic drape is applied to the skin on and around the eyelids and the eyelashes are excluded from the operative field by folding the edges of the drape around them and inserting a self-retaining speculum to hold the lids open. Primary incision is created or opened by 2.8mm keratome (if not made with laser) and hydration is done by hydration cannula after removing the anterior capsule rhexis. Viscoelastic substance is instilled and phaco probe is inserted to aspirate the cortex. Residual cortical matter is aspirated manually using a two-way irrigation-aspiration cannula or an auto mated irrigation-aspiration probe. A posterior chamber intraocular lens(ray is then implanted in the bag. Residual viscoelastic substances are aspirated at the end of surgery. After ensuring wound integrity eye is patched after instilling vigamox 0.5%.

Post operatively on Day 1, Day 7 patient vision will be recorded using Snellens chart. On day 1, day 7and day 30 endothelial cell count and central corneal thickness will be measured using specular microscope. Slit lamp examination to assess conjunctiva, cornea, anterior chamber, pupil, implanted IOL and fundus examination using 90D will be done on every visit.

 
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