| 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
|
|
|
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
|
|
|
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 |
| â— 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.
|