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Clinical Trials/CTRI/2024/06/069054
CTRI/2024/06/069054Not yet recruitingPhase 3

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

Northern Railway Central Hopital1 site in 1 country40 target enrollmentStarted: June 27, 2024Last updated:

Trial Snapshot

Phase
Phase 3
Status
Not yet recruiting
Sponsor
Enrollment
40
Locations
1
Primary Endpoint
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.

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Coin toss, Lottery, toss of dice, shuffling cards etc
Masking
Participant and Investigator Blinded

Eligibility Criteria

Ages
40.00 Year(s) to 85.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • 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.

Exclusion Criteria

  • Pathology of corneal endothelium.
  • Patients with neck and back rigidity.
  • Advanced glaucoma
  • ACD less than 3MM
  • Complicated cataract.

Outcomes

Primary Outcomes

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.

Time Frame: pre-op and post op day 1 day7 day 30 .

Secondary Outcomes

  • ● 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 .)

Investigators

Sponsor
Northern Railway Central Hopital
Sponsor Class
Research institution and hospital
Responsible Party
Principal Investigator
Principal Investigator

Kanchan Mala

Northern Railway Central Hospital

Study Sites (1)

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