POST CATARACT SURGERY WITH AND WITHOUT STEROID EYE DROPS Â

Not Applicable

• Conditions: Health Condition 1: H251- Age-related nuclear cataract

• Registration Number: CTRI/2022/04/042105
• Lead Sponsor: Aravind Eye Care System AECS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 2 May 2022

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1.Age 40 to 75 years

2.Patients undergoing topical phacoemulsification with monofocal foldable IOL implantation

3.Senile cataract

4.Axial length of 20.5 to 25mm

5.Staying within 100 kms from base hospital and willing for all follow up visits

Exclusion Criteria

1.Age <40 years

2.Diabetes retinopathy

3.Advanced cataract (BCVA 3/60 or less)

4.NSIV, Posterior polar, subluxated , traumatic, complicated and developmental cataract

5.Pregnant and lactating women

6.Patients with mental illness

7.Non visualization of fundus

8.CDR of 0.7 & more

9.IOP of 21 & above

10.Known case of glaucoma diagnosed based on cup disc ratio, field defects, RNFL defects or raised

IOP and on treatment for the same

11.Family history of glaucoma

12.H/O steroid responsiveness

13.On systemic steroids for asthma, rheumatoid arthritis or other illness or history of steroid use by any route in the prior 3 months

14.Corneal diseases

15.Prior incisional ocular surgery

16.Associated ocular comorbidity (ARMD, pseudo exfoliation, small pupil (5mm or less), floppy iris, corneal opacity, macular scar, epiretinal membrane, retinal detachment, uveitis, shallow anterior chamber)

17.Central macular thickness (CMT) >250 μ to rule out macular edema and pachychoroid

18.Subfoveal choroidal thickness (SFCT) >300 μ

19.Presence of pachyvessels on EDI (enhanced depth imaging) OCT

20.On alpha adrenergic blockers for benign prostatic hypertrophy

21.Any intraoperative complications (PCR , ZD , Nucleus drop, Vitreous loss, iris injury)

22.Axial length <20.5mm and > 25mm

23.Any intraoperative complications (PCR , ZD , Nucleus drop, Vitreous loss)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Visual outcome with refractive erros <br/ ><br>Timepoint: 12 months <br/ ><br>

Secondary Outcome Measures

Name	Time	Method
1) Macula thickness 2) Incidence of CME 3) On additional medication for raised IOP/ glaucoma due to steroids 4) On additional medication for break through iritisTimepoint: 12 months <br/ ><br>