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A computerized visual training study for visual stimulation in cataract patients following diffractive Intra Ocular lens Implantation.

A Proof-of-Concept, Prospective, Open label, Randomized Controlled Clinical Study Evaluating RevitalVision® Therapy for Improving Uncorrected Visual Acuity (UCVA) and Contrast Sensitivity Function (CSF) in Cataract Patients Following Diffractive IOL Implantat.

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/08/045110
Enrollment
55
Registered
2022-08-31
Start date
Unknown
Completion date
Unknown
Last updated
2023-03-06

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

Conditions

Health Condition 1: H530- Amblyopia ex anopsia

Interventions

Intervention1: RevitalVision, a interactive web-based computer software training: 40 patients who undergone Diffractive IOL implantation, will be having interactive web-based computer software trainin

Sponsors

None
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Subject, man & woman 50 to 80 years old, post cataract surgery with Diffractive IOL implants 12 to 52 weeks following surgery. 2. Subject with BCVA better than 6 of 9 at least in one eye. 3. Subject with UCVA 6by6 â?? 6 of 15 at least in one eye. 4. Subject with Contrast Sensitivity Function below-normal range, measured in FACT sine wave test chart during screening visit. 5. Subject complaining on vision quality. 6. Subject is able to sign on informed consent. 7. Subject is willing and declare his/her motivation to practice 3 to 4 times per week x 30 minutes each training, for 8 consecutive weeks. 8. Subject who is able to participate in complete ophthalmic and ocular evaluation based on the study PI decision. 9. Subject has a Personal Computer with window OS or MAC IOs (Operating System) with screen size 15-26 inch at home and with internet connection. 10. Subject pass successfully Computerized Evaluation 1 and 2 as defined by RV system.

Exclusion criteria

Exclusion criteria: 1. Subject who has unstable vision based on PI decision 2. Subject with severe untreated attention disorder. 3. Subject who suffer from chronic migraines based on subject self-reporting 4. Subject who diagnosed with Epilepsy 5. Subject who has any ocular disease beside cataract. 6. Subject who has any behavioral or neurological disorders which may interfere with the study, based on PI discursion 7. Subject who has any physical or mental impairment precluding study compliance, based on PI discursion 8. Unstable health condition, which may prevent from completing the study and follow up visits. Based on PI decision. 9. Treated with medication that may affect vision quality.

Design outcomes

Primary

MeasureTime frame
Percentage of patients improving Distance Contrast Sensitivity Function by at least 50% in Functional Acuity Contrast Test sine wave (FACT) at study end in comparison to baseline.Timepoint: 8-10 weeks

Secondary

MeasureTime frame
Percentage of patients improving Uncorrected Distance & Near Visual Acuity by at least 1 line at study end in comparison to baseline.Timepoint: 8-10 weeks

Countries

India

Contacts

Public ContactProf A Heber

Dr. Agarwals Eye Hospital

drlionalraj@dragarwal.com8754411261

Outcome results

None listed

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