CTRI/2019/06/019697
Other
未知
A Clinical Study to evaluate the Outcome after implantation of two different commercially available Intra Stromal Rings combined with Collagen cross linking in patients with Keratoconus
Biotech Vision Care Pvt Ltd0 sites3 target enrollmentTBD
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Biotech Vision Care Pvt Ltd
- Enrollment
- 3
- Status
- Other
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Unilateral/bilateral
- •2\. A diagnosis of keratoconus, intolerance for contact lenses or glasses.
- •3\. Progressing keratoconus. (Decrease in visual acuity of at least 1 line excluding non\-corneal causes of deterioration/ steepening of at least 1D in steepest keratometry over last 6 months/ more than 1 in prescription of change of glasses or contact lens over the last 2 years)
- •4\. Patients with Keratometric readings ââ?°Â¥ 48 D
- •5\. Patients ââ?°Â¥ 18 years of age
- •6\. Patients with clear cornea
- •7\. Patients with corneal thickness ââ?°Â¥ 450 microns at the proposed incision site.
- •8\. Patient willing to participate and sign informed consent
- •9\. Patient willing to come for all post\-operative follow\-up procedures as defined in study protocol.
Exclusion Criteria
- •1\. Patients with maximum keratometry (K) values greater than 65\.00 diopters (D),
- •2\. Patients with keratometric readings \< 48 D
- •3\. Apical opacity and scarring.
- •4\. Hydrops.
- •5\. Previous corneal or Intraocular surgery
- •6\. Corneal thickness less than 450 microns at the planned site of Intrastromal rings implantation (5\.0 mm optical zone).
- •7\. Pregnancy \& Lactation
- •8\. Concurrent participation in another drug or device Study.
Outcomes
Primary Outcomes
Not specified
Similar Trials
Completed
Not Applicable
A clinical study for evaluating of the effect of a supplement containing plant extract on the gut microbiome. -A Randomized, Double-blind, Placebo controlled, parallel-group StudyHealthy subjects with a tendency for constipationJPRN-UMIN000047224FUKUOKA KINEN PET KENSHIN CENTER30
Completed
Not Applicable
A clinical study for evaluating of the effect of a complex food on postprandial serum triglyceride.JPRN-UMIN000029484Iryouhoujinsyadan Shoureikan Shinsapporo Seiryou Hospital40
Completed
Not Applicable
Clinical Investigation of Patient Outcomes after IOL Implantation with Different IOL Delivery SystemsH26.9Cataract, unspecifiedDRKS00020134Alcon Research, LLC24
Active, not recruiting
Not Applicable
A Follow-Up Study of Schizophrenic Participants Following Treatment Discontinuation After Remission From a First Psychotic EpisodeEUCTR2015-001221-16-Outside-EU/EEAJanssen Cilag N.V./S.A33
Completed
Not Applicable
A clinical study for evaluating the effects of the combined administration of L-citrulline and L-arginine on blood arginine and NOx levelsoneJPRN-UMIN000016647Soiken Inc.40