Contrast Sensitivity Assessment in Pediatric Cataract Surgery With IOL Implantation

NCT01901744 | Completed DMC

• 1 other identifier: 12-008
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

The study evaluates contrast sensitivity in older children following surgery for lamellar and posterior subcapsular cataracts. Often, pediatric surgeons tend to delay surgery in these children who present beyond the amblyogenic age group. These cataracts are often compatible with reasonable visual acuity and therefore some surgeons prefer to wait for surgery, whereas others tend to operate. The study evaluates improvement in contrast sensitivity at different spatial frequencies following cataract surgery for lamellar and posterior subcapsular cataracts in older children.

Conditions

Contrast Sensitivity

Keywords

Contrast Sensitivity , Pediatric Cataract Surgery,

Outcome Measures

Primary Outcomes (1)

• Contrast Sensitivity at 3, 6, 12 and 18 cycles per degree under photopic and mesopic conditions pre and post cataract surgery

  Preoperative and 1 and 3 months postoperatively contrast sensitivity testing would performed using the CSV 1000E sine wave grating test face (Vector Vision, USA) with the patient seated at a distance of 2.5 m from the chart. The test is performed after the patient was adapted to the room luminance for 5 minutes. The non viewing eye is occluded for each measurement, and the best spectacle refractive correction is placed in front of the viewing eye. Testing is performed at preoperative 3, 6, 12 and 18 cycles per degree, each spatial frequency being tested under two lighting conditions: photopic (85cd/m2) and mesopic (2.7cd/m2). The contrast sensitivity values are documented in log units. Sensitivity levels at each frequency range from 0.7 to 2.08 (3 cpd), 0.91 to 2.29 (6 cpd), 0.61 to 1.99 (12 cpd), and 0.17 to 1.55 (18 cpd) log units. This testing is performed with the patient wearing their refractive correction in form of spectacles.

  up to 3 months postoperatively

Secondary Outcomes (1)

• Improvement in Best Corrected Snellen's Visual Acuity following Cataract Surgery

  1 and 3 months postoperatively

Study Arms (1)

Patients undergoing cataract surgery

EXPERIMENTAL

Procedure: Cataract Surgery

Interventions

Cataract Surgery PROCEDURE

Patients undergoing cataract surgery

Eligibility Criteria

• Age: 1 Year - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children older than 4 years and lamellar and posterior subcapsular cataracts undergoing cataract surgery with IOL implantation

You may not qualify if:

• eyes with traumatic or subluxated cataract,

Sponsors & Collaborators

• Iladevi Cataract and IOL Research Center: lead

Study Sites (1)

Iladevi Cataract & IOL Research Centre

Ahmedabad, Gujarat, 380 052, India

Location

MeSH Terms

Interventions

Cataract Extraction

Intervention Hierarchy (Ancestors)

Refractive Surgical Procedures; Ophthalmologic Surgical Procedures; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Iladevi Cataract and IOL Research Center

Study Record Dates

• First Submitted: July 1, 2013
• First Posted: July 17, 2013
• Study Start: January 1, 2009
• Primary Completion: July 1, 2011
• Study Completion: January 1, 2013
• Last Updated: July 17, 2013

Record last verified: 2013-07

Locations

IN (1)