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Need for steroid use after routine cataract surgery

Are steroids required to control post-operative inflammation after uncomplicated phacoemulsification surgery? - SEC08201301

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2016/04/006806
Enrollment
240
Registered
2016-04-07
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Those undergoing cataract surgery by standard phacoemulsification and hydrophobic foldable intraocular lens implantation

Interventions

Intervention1: ketorolac tromethamine ophthalmic solution) 0.45%: INDICATIONS AND USAGE Ketorolac Tromethamine ophthalmic solution is a nonsteroidal, antiinflammatory indicated for the treatment of pa
sodium bisulfite
sodium chloride
and sodium citrate. The pH during its shelf life ranges from 5.0 - 6.0. CLINICAL PHARMACOLOGY Prednisolone acetate is a glucocorticoid that, on the basis of weight, has 3 to 5 times the anti-inflammat

Sponsors

The Calcutta Medical Research Institute
Lead Sponsor
Allergan India Private Limited
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: 1. Uncomplicated cases of Phacoemulsification with IOL implantation. Uncomplicated being defined as a. No capsular dehiscence b. Placement of single piece foldable IOL in the capsular bag c. No sutures applied 2. Includes surgeries where there have been iris handling/trauma (e.g. due to IFIS) or where iris retractors were used 3. Includes surgeries done under GA/Peri-bulbar block/Topical anaesthesia 4. Includes per-operative use of intra-cameral adrenaline and/or trypan blue

Exclusion criteria

Exclusion criteria: 1. Presence of intra-ocular inflammation. 2. History of uveitis â?? anterior/posterior/pan. 3. Rubeosis iridis. 4. Diabetic eye disease including any diabetic retinopathy (even background). 5. History of herpes simplex/HZO (as there may be corneal anaesthesia and subsequent epithelial problems with NSAID therapy). 6. Glaucoma patients on prostaglandin analogue medication. 7. Ocular surface damage secondary to dry eye disease involving staining of the cornea. Conjunctival staining alone is not an exclusion criteria. 8. Use of per-operative intra-cameral antibiotics and/or lignocaine 9. Any intraocular procedure in the last 3 months. 10. Lost to follow up.

Design outcomes

Primary

MeasureTime frame
Anterior segment inflammation PainTimepoint: 1,3 and 5 weeks post surgery

Secondary

MeasureTime frame
Cystiod macular oedemaTimepoint: 1,3 and 5 weeks post surgery

Countries

India

Contacts

Public ContactDr Bhaskar Ray Chaudhuri

The Calcutta Medical Research Institute

brc_cmri@yahoo.com09830024939

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026