Clinical Evaluation of Efficacy and Stability of AT TORBI 709M 4-haptic Toric IOL in Cataract Surgery

• Sponsor: Seoul National University Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02618018
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arm: 1
• Duration (Months): 15
• Patients Per Site Per Month: 1.3

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the efficacy and stability of AT TORBI 709M 4-haptic toric IOL in cataract surgery.

Condition or Disease	Intervention/Treatment	Phase
Iol; Astigmatism	Procedure: AT TORBI 709M	N/A

Detailed Description

Inclusion criteria

1. senile cataract

2. patients' age of 21 years or older

3. preoperative regular corneal astigmatism between 1.00 D and 6.00 D

Exclusion criteria

1. pregnant, lactating women

2. presence of other ocular diseases which affect stability of lens capsule

Primary outcome : efficacy index (visual acuity, refractive results Secondary outcome :

rotational stability, endothelial cell count, cornea thickness

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Investigator-Initiated Trials on the Efficacy and Stability of AT TORBI 709M 4-haptic Toric IOL in Cataract Surgery
• Study Start Date: Sep 1, 2015
• Anticipated Primary Completion Date: Dec 1, 2016
• Anticipated Study Completion Date: Dec 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: intraocular lens AT TORBI 709M toric intraocular lens	Procedure: AT TORBI 709M; Cataract surgery with AT TORBI 709M 4-haptic toric IOL

Outcome Measures

Primary Outcome Measures

1. Visual acuity, refractive results [3 months]

   uncorrected distance visual acuity (UCDVA) and best corrected distance visual acuity (BCDVA) measured using logarithm of the minimum angle of resolution (logMAR) refractive results measured by keratometry

Secondary Outcome Measures

1. Rotational stability [3 months]

   Photographic evaluation of IOL rotation using slit-lamp digital photographs at each postoperative visit, and determine changes in the lens axis between visits.

2. Endothelial cell count [3 months]

   measured by specular microscopy

3. Cornea thickness [3 months]

   measured by ultrasound pachymetry

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• senile cataract

• patients' age of 21 years or older

• preoperative regular corneal astigmatism between 1.00 D and 6.00 D

Exclusion Criteria:

• pregnant, lactating women

• presence of other ocular diseases which affect stability of lens capsule

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul National University Hospital	Seoul		Korea, Republic of	110-744

Sponsors and Collaborators

• Seoul National University Hospital

Investigators

• Principal Investigator: Mee Kum Kim, MD, PhD, Seoul National University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Seoul National University Hospital
• ClinicalTrials.gov Identifier: NCT02618018
• Other Study ID Numbers: AT TORBI 709M toric IOL
• First Posted: Dec 1, 2015
• Last Update Posted: Dec 1, 2015
• Last Verified: Nov 1, 2015

• Keywords provided by Seoul National University Hospital: astigmatism; toric intraocular lens
• Additional relevant MeSH terms: Cataract; Astigmatism

Study Results

No Results Posted as of Dec 1, 2015