A trial to compare the outcomes of new lens having heparin coated surface with currently being used lens(without heparin coating) in diabetic patients with cataract

Clinical Evaluation of Aspheric Heparin Surface Modified Hydrophobic Foldable Intra Ocular Lens (IOL) in Diabetic Patients

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2016/02/006624

Enrollment

100

Registered

2016-02-11

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- diabetic patient with cataract admitted for cataract surgery(phacoimulsification) with intraoccular lens(IOL) implantation.

Interventions

Intervention1: CT LUCIA 601PY intraocular lens(IOL): Hydrophobic acrylic foldable with heparin coated surface Monofocal, Aspheric (- 0.12) Control Intervention1: SN60WF inra ocular lens(IOL): Hydrop

Eligibility

Inclusion criteria

Inclusion criteria: 1 Diabetes mellitus 2 Age â?? 45 years or above 3 Presence of cataract sufficient to cause visual symptoms in patients with diabetes mellitus requiring medical control 4 Patients with no evidence of diabetic retinopathy or mild to moderate non proliferative diabetic retinopathy without maculopathy 5 Patient willing to give informed consent 6 Patients willing to come for follow ups

Exclusion criteria

Exclusion criteria: Presence of coexistent ocular disease likely to modify visual acuity other than diabetic retinopathy (eg, age-related macular degeneration, amblyopia, or retinal venous occlusion) Proliferative or very severe non proliferative diabetic retinopathy and clinically significant macular edema Iris neovascularization Prior intraocular surgery (eg, trabeculectomy or vitrectomy Intraocular tumors Pseudoexfoliation syndrome Intraoperative capsule complications such as anterior or posterior capsule tears Use of oral steroids or glaucoma medications Patients not giving consent for the study Patients not willing for follow up

Design outcomes

Primary

Measure	Time frame
Comparison of aqueous cell flare Macular thickness by spectral domain OCTTimepoint: preoperatively and post operative day 1,day 7,day 14, day 21, day 28 ,2 months 3 month ,6 month ,one year	—

Secondary

Measure	Time frame
Visual acuity(uncorrected and best corrected) Intraocular pressure Posterior capsule status Intraocular lens position and surface Fundus evaluationTimepoint: preoperatively and post operative day 1,day 7,day 14, day 21, day 28 ,2 months 3 month ,6 month ,one year	—

Countries

India

Contacts

Public ContactDivya Kumari

Dr R P centre for ophthalmic Sciences ,Aiims, New Delhi

divsdraiims@gmail.com8098843503

Outcome results

None listed

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