Comparison between post op dropless treatment versus traditional with drop treatment

Phase 4

Not yet recruiting

Conditions: Other age-related cataract,

Registration Number: CTRI/2025/04/084964

Lead Sponsor: Nethradhama Super Speciality Eye Hospital

Brief Summary: InstitutionalEthics committee approval will be obtained and trial registered with ClinicalTrial Registry of India.

Patientsinformed consent will be taken and the procedure explained to them in their ownlanguage.

*Studydesign*: Prospective, randomized, comparative, hospital-based, single centerinterventional clinical study in patients with planned phacoemulsifictionsurgery.

*StudySetting*: Nethradhama Superspeciality Eye Hospital, Bangalore.

*Patientselection criteria:*

Patientswill be enrolled into the clinical study and randomized in a ratio of 1:1 bysimple random sampling through computer generated lottery method.

Thepatients will also be willing to attend routine follow-up care as describedbelow (1 day up to 6 months post-surgery).

StudyDuration: Time frame for patient visits and examination are pre-operative, dayof surgery, postoperative days 1, 15, month 1, 3 and 6

Method ofdata collection:

Datawill be collected on the demographic profile (age, gender, address, andoccupation) and ocular parameters of the patients, as measured by slit lampexamination, 90D lens with slit lamp, and indirect ophthalmoscopy.

Before thesurgery, all patients will undergo a complete ophthalmic examination includingsubjective refraction, slit lamp biomicroscopy, noncontact tonometry (TopconCT-80), dilated fundus examination, OCT macula. (Optovue RTVue 100, USA)

Thestudy participants will be divided into two groups –

StudyGroup: Sub-Tenon’s triamcinolone acetonide (12 mg/ml) and 0.1ml intracameralmoxifloxacin (0.5%) (Auromox, Aurolab, India) administered at the end ofsurgery.

ControlGroup: Standard post-operative topical antibiotic-steroid regimen

Interventionand Procedure:

PhacoemulsificationSurgery: All patients will undergo either standard phacoemulsification cataractsurgery or Femstosecond assisted laser assisted phacoemulsification by a singlesurgeon. All procedures will be conducted under topical anesthesia.

PostoperativeIntervention:

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 320

Inclusion Criteria

Primary cataract surgery (age-related cataract) requiring phacoemulsification.
Patients with cataracts with nuclear opalescence grade 1-3, cortical cataract, posterior subcapsular cataract Preoperative best-corrected visual acuity worse than 20/40.
No history of ocular trauma, glaucoma, diabetic retinopathy, or other retinal pathology.

Exclusion Criteria

History of previous eye surgery (except for uncomplicated cataract surgery in the other eye).
Active ocular infection or inflammation (KNOWN CASE OF HSV OR RETROVIRAL/HEPATITIS) .
Systemic conditions contraindicating steroid use (e.g., active systemic infection, poorly controlled diabetes).
Complicated cataracts History of uveitis, glaucoma, HIGH myopia.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
OCT - macula- central sub retinal thickness (Optovue RTVue100, USA) - 15 days	postoperative days 1, 15, month 1, 3 and 6
Intraocular Pressure (IOP) at postoperative day 1, 15 days, month 1, 3, and 6.	postoperative days 1, 15, month 1, 3 and 6
AC reaction (measured via anterior chamber cell count and flare according to SUN classification) - as measured on slit lamp.	postoperative days 1, 15, month 1, 3 and 6
Best-Corrected Visual Acuity (BCVA) at postoperative day 1, 15 days, month 1, 3, and 6.	postoperative days 1, 15, month 1, 3 and 6

Secondary Outcome Measures

Name	Time	Method
Rate of Postoperative Complications (e.g., endophthalmitis, posterior capsule opacification, macular edema, elevated IOP).	Patient Satisfaction (subjective questionnaire at 1 and 3 months).

Trial Locations

Locations (1): Nethradhama Super Speciality Eye Hospital
🇮🇳
Bangalore, KARNATAKA, India
Nethradhama Super Speciality Eye Hospital
🇮🇳Bangalore, KARNATAKA, India
DrManasaveenaNT
Principal investigator
9060630060
manasa.veena2412@gmail.com