ClinicalTrials.gg
Status unknownNCT04120389Updated Apr 5, 2021

Efficacy of an Ocular Bandage Contact Lens for the Treatment of Dry Eye After Complicated and Combined Cataract Surgery

An interventional study of bandage contact lenses(PureVision; Bausch & Lomb Inc., Rochester, NY) and phacoemulsification in Cataract, Lens Subluxation and Hypermature Cataract, sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. Status unknown at 1 site in China. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-04-05.

Sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jan 2021), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
40 Years to 80 Years
Sex
All
01

Study summary

To study the efficacy of an ocular bandage contact lens for the treatment of dry eye after complicated and combined cataract surgery

02

Conditions studied

  • Cataract
  • Lens Subluxation
  • Hypermature Cataract
  • Corneal Opacity
  • Small Pupil

Keywords

  • Bandage contact lens
  • cataract surgery
  • dry eye
03

In context

Cataract

1,629 studies on the registry are indexed under Cataract; 235 are open to participants now.

This study's planned enrollment of 30 is below the median of 79 across 1,092 interventional studies indexed under Cataract.

Browse Cataract studies →

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University is the lead sponsor of 1,047 studies on the registry; 502 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. cataract patients(age 40-80)
  2. complex symptom(such as:corneal opacity、small pupil、zonule relaxationlens subluxation、Shallow Anterior Chamber、hypermature cataract、hard nucleus,etc)
  3. dry eye disease

Exclusion criteria

Exclusion Criteria:

  1. simplex age-related cataract
  2. contact lens use
  3. ocular therapies such as 0.05% cyclosporine A or in the last 3 months
  4. any systemic diseases such as heart diseases, diabetes and psychosis
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    BCL group

    bandage contact lenses(PureVision; Bausch \& Lomb Inc., Rochester, NY)

    Device: bandage contact lenses(PureVision; Bausch & Lomb Inc., Rochester, NY) · Procedure: phacoemulsification

  • Active comparator
    control group

    Procedure: phacoemulsification

Interventions

  • Devicebandage contact lenses(PureVision; Bausch & Lomb Inc., Rochester, NY)

    wear an bandage contact lenses for a week after Complicated and Combined cataract surgery.

  • Procedurephacoemulsification

    underwent standard phacoemulsification through a 2.8-mm clear corneal temporal incision and intraocular lens

06

What researchers measure

Primary outcomes

  1. Ocular Surface Disease Index questionnaire

    Ocular Surface Disease Index questionnaire were included 12 questions,and each was rated from 0-4

    Time frame: 0 day preoperatively

  2. Ocular Surface Disease Index questionnaire

    Ocular Surface Disease Index questionnaire were included 12 questions,and each was rated from 0-4

    Time frame: 1 day postoperatively

  3. Ocular Surface Disease Index questionnaire

    Ocular Surface Disease Index questionnaire were included 12 questions,and each was rated from 0-4

    Time frame: 1 week postoperatively

  4. Ocular Surface Disease Index questionnaire

    Ocular Surface Disease Index questionnaire were included 12 questions,and each was rated from 0-4

    Time frame: 1 month postoperatively

  5. Ocular Surface Disease Index questionnaire

    Ocular Surface Disease Index questionnaire were included 12 questions,and each was rated from 0-4

    Time frame: 3 months postoperatively

  6. Tear Breakup Time

    Tear Breakup Time was performed to assess tear film stability

    Time frame: 0 day preoperatively

  7. Tear Breakup Time

    Tear Breakup Time was performed to assess tear film stability

    Time frame: 1 week postoperatively

  8. Tear Breakup Time

    Tear Breakup Time was performed to assess tear film stability

    Time frame: 1 month postoperatively

  9. Tear Breakup Time

    Tear Breakup Time was performed to assess tear film stability

    Time frame: 3 months postoperatively

  10. Schirmer test with anesthesia

    The Schirmer test was performed by inserting a test strip

    Time frame: 0 day preoperatively

  11. Schirmer test with anesthesia

    The Schirmer test was performed by inserting a test strip

    Time frame: 1 week postoperatively

  12. Schirmer test with anesthesia

    The Schirmer test was performed by inserting a test strip

    Time frame: 1 month postoperatively

  13. Schirmer test with anesthesia

    The Schirmer test was performed by inserting a test strip

    Time frame: 3 months postoperatively

Secondary outcomes

  1. Subjective symptoms

    Subjective symptoms evaluation related to 11 ocular symptoms ,and each was graded as follows:0 never、1 occasional、2 often、3 always

    Time frame: 0 day preoperatively

  2. Subjective symptoms

    Subjective symptoms evaluation related to 11 ocular symptoms ,and each was graded as follows:0 never、1 occasional、2 often、3 always

    Time frame: 1 day postoperatively

  3. Subjective symptoms

    Subjective symptoms evaluation related to 11 ocular symptoms ,and each was graded as follows:0 never、1 occasional、2 often、3 always

    Time frame: 1 week postoperatively

  4. Subjective symptoms

    Subjective symptoms evaluation related to 11 ocular symptoms ,and each was graded as follows:0 never、1 occasional、2 often、3 always

    Time frame: 1 month postoperatively

  5. Subjective symptoms

    Subjective symptoms evaluation related to 11 ocular symptoms ,and each was graded as follows:0 never、1 occasional、2 often、3 always

    Time frame: 3 months postoperatively

  6. Fluorescein Staining

    The corneal surface was divided into four regions, and each region was scored as follows: 0, no staining; 1, between one and three dots; 2, less than five dots; and 3, bulk or strip staining. The four regions scores were then added to obtain a final score for the eye

    Time frame: 0 day preoperatively

  7. Fluorescein Staining

    The corneal surface was divided into four regions, and each region was scored as follows: 0, no staining; 1, between one and three dots; 2, less than five dots; and 3, bulk or strip staining. The four regions scores were then added to obtain a final score for the eye

    Time frame: 1 week postoperatively

  8. Fluorescein Staining

    The corneal surface was divided into four regions, and each region was scored as follows: 0, no staining; 1, between one and three dots; 2, less than five dots; and 3, bulk or strip staining. The four regions scores were then added to obtain a final score for the eye

    Time frame: 1 month postoperatively

  9. Fluorescein Staining

    The corneal surface was divided into four regions, and each region was scored as follows: 0, no staining; 1, between one and three dots; 2, less than five dots; and 3, bulk or strip staining. The four regions scores were then added to obtain a final score for the eye

    Time frame: 3 months postoperatively

Other outcomes

  1. Best Corrected Visual Acuity

    The BCVA was measured by the same optometrist at each visit

    Time frame: 0 day preoperatively

  2. Best Corrected Visual Acuity

    The BCVA was measured by the same optometrist at each visit

    Time frame: 1 day postoperatively

  3. Best Corrected Visual Acuity

    The BCVA was measured by the same optometrist at each visit

    Time frame: 1 week postoperatively

  4. Best Corrected Visual Acuity

    The BCVA was measured by the same optometrist at each visit

    Time frame: 1 month postoperatively

  5. Best Corrected Visual Acuity

    The BCVA was measured by the same optometrist at each visit

    Time frame: 3 months postoperatively

07

Study locations

1 of 1 sites recruiting
  • Second Affiliated Hospital, Zhejiang University School of Medicine
    Hangzhou, Zhejiang 310009, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 5, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04120389
Responsible party
Sponsor
First posted
Oct 9, 2019
Start date
Mar 13, 2020
Primary completion
Dec 31, 2021 (estimated)
Completion
Dec 31, 2021 (estimated)
Last update
Apr 5, 2021

Study contacts

wen xu, PHD
Contact
xuwen2003@zju.edu.cn
+86 571 87783897

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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